EQUIPMENT & FACILITY QUALIFICATION ENGINEER Job Dept: Engineering Reports to: Engineering Manager Responsibilities: <ul><li>Generation, Execution / Approval of Qualification Life Cycle documents from System Classification, P/GURS, Risk Assessments / FMEA through to IOQ and Final Summary Reporting for Direct Impact Systems.</li><li>Generation of Commissioning Test documents for No Impact Systems.</li><li>Implementation of Change Controls on the change management system to support project activities as applicable.</li><li>The role requires someone to coordinate and manage all elements of commisioning & qualification of new and existing cleanroom facilitties and automated medical device assembly equipment.</li></ul>Responsibilities will be but are not limited to: <ul><li>Developing a project plan and qualification startegy in line with organisations requirements.</li><li>Project activities may include but not are not limited to the following: Medical Device assembly equipment, Utilities, HVAC & Facilities.</li><li>Coordinate and supervise third party suppliers / vendors , service providers and sub-contractors as necessary.</li><li>Monitor and report on project plan progress, communicate any shortfalls in specific areas of the plan and where needed identify solutions to address the shortfalls.</li><li>Organise and or attend any necessary meetings that are required for progress gathering or plan alignment</li><li>Participate in decision forums to decide on priorities and ensure these are reflected in the plan, schedule and communications.</li><li>Where needed evaluate allocation of resources needed to complete project tasks and provide recommendations to maintain required progress.</li><li>To communicate with project stakholders required support and completion dates.</li><li>If assigned a budget for project execution: Monitor budgets closely reporting on funding committed, expenditure forecasting and progress. </li></ul>  Requirements: <ul><li>Degree in Engineering or related discipline is a necessary requirement for this position with project management experience.</li><li>Good interpersonal and coordination skills</li><li>5 years' experience in projects in the Pharmaceutical or BioTech /Medical devices sector or Major project environment.</li><li>Knowledge & experience of, Microsoft Project , Good computer literacy including MS office and excel</li><li>Team worker</li><li>Project focused</li></ul> For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Equipment & Facility Qualification Engineer

AUTOMATION PROJECT ENGINEER Job Dept: Engineering Reports to: Project & Automation Manager Responsibilities: <ul><li>To provide technical support and project management to all manufacturing operations and NPI’s throughout the site.</li><li>To provide technical leadership of all control system activities in the medical device manufacturing facilities.</li><li>Ability to take active lead on control system qualification activities during project start-up.</li><li>In conjuction with IT / BTS, lead the integration of new systems to the organisations Network</li><li>Project management of control system elements of new and continuous improvement projects. Work closely with process engineers and other departments to deliver these projects.</li><li>Project management and technical development of future integrations of the control systems, with planned MES/ERP/Data Historian (OSI PI) systems.</li><li>Life cycle management of the on-site control systems to the organisations SLC & applicable regulatory requirements.</li><li>Provide technical support to all control system related issues. Tasks include, daily trouble shooting, optimisation, and documentation control.</li><li>Adheres to and supports all EHS & E standards, procedures and policies.</li><li>Identify opportunities and assist in leveraging of vendor qualification efforts, developing relationships with vendors, and act as Engineering representative for pre-approval of vendor documentation.</li></ul>   Requirements: <ul><li>NFQ Level 8 Honors Bachelor’s Degree or Higher Diploma in a relevant technical discipline.</li><li>3 years plus experience in an automation engineering role, with software development of PLC /HMI / SCADA platforms in a GMP pharmaceutical industry environment.</li><li>3 years plus experience of the 21 CFR Part 11 requirements for automated systems in the pharmaceutical industry.</li><li>3 years plus of Experience of plant start-ups and/or new product introductions to medical device facilities. Must be able to lead these activities in a start-up environment.</li><li>Experience in qualification of control systems is essential.</li><li>Experience in auditing and internal inspection would be advantageous.</li></ul> For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Automation Project Engineer

Visual Inspection Engineer Job Dept: Operations Reports to: Operations Lead   Responsibilities: <ul><li>To work as a team member to support Visual Inspection operations in line with all safety, regulatory and organizational requirements.</li><li>Develop and modify procedures as needed to support the manufacturing operation.</li><li>Participate in process, equipment, and facilities validations efforts and projects implementations.</li><li>Review and approve process related commissioning, qualification and validation protocols for completeness and accuracy.</li><li>Execute protocols in a timely basis to meet the project schedule requirements.</li><li>Participate and lead (as required) Process FMEAs for Visual Inspection</li><li>Establish, Lead and Optimize the process for certification of technicians for visual inspection.</li><li>Establish and maintain the defect library.</li><li>Establish and execute the process for the trending of Visual Inspection Defects.</li><li>Ensure all Site Visual Inspection procedures are aligned with Global Guidance Documents and Regulatory Requirements</li><li>Provide Technical Input to guide the development of SOPs for Visual Inspection.</li><li>Leadership of manufacturing and validation activities during project life cycle.</li><li>Coordination with internal/external stakeholders for the evaluation of particles/defects</li><li>Support of technical transfers for future product introductions to the site.</li><li>Investigate process exceptions or malfunction incidents affecting the process.</li><li>To liaise with Internal/External Engineering Personnel and Internal/External Quality personnel as required</li><li>Support the Production Team in ensuring that manufacturing process is enabled and maintained to meet the output and yield requirements.</li></ul> Essential Requirements: <ul><li>A relevant third level qualification in an engineering, science or technical discipline (Degree Level or Masters Preferable)</li><li>At least three (3) years of total combined experience in Technical/Operations/Operations/Quality or equivalent in a Pharmaceutical and Health Care Organization.</li><li>At least three (3) years of experience in the manufacturing environment of a biotechnology, pharmaceutical or health care plant.</li><li>Previous experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, fill finish, Lyophilisation, sterilisation operations preferable.</li><li>Experience in clean utilities is desirable.</li></ul> For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Visual Inspection Engineer

Continuous Improvement Manager Location: Limerick, Ireland *Contract position* Job Description: Our Client is seeking a results-driven Continuous Improvement Manager to lead operational excellence initiatives at their Limerick facility. In this role, you will be responsible for identifying, managing, and executing strategic process improvement projects that drive efficiency, quality, and cost-effectiveness across manufacturing and support functions. You will collaborate cross-functionally to embed Lean, Six Sigma, and best-in-class CI practices, fostering a culture of continuous improvement and high performance. Key Responsibilities: <ul><li>Lead and manage CI projects using Lean and Six Sigma methodologies.</li><li>Identify opportunities for process optimisation, waste reduction, and productivity enhancement.</li><li>Coach and support teams in applying CI tools and problem-solving techniques.</li><li>Develop KPIs to measure improvement impact and track project success.</li><li>Support strategic initiatives aligned with corporate and site-level goals.</li><li>Promote a culture of continuous improvement across all departments.</li></ul> Qualifications: <ul><li>Bachelor’s degree in Engineering, Science, Business, or related field.</li><li>7+ years’ experience in a manufacturing or operations environment.</li><li>Proven expertise in Lean, Six Sigma (Green Belt or Black Belt preferred).</li><li>Strong leadership, facilitation, and change management skills.</li><li>Medical device or regulated industry experience is a plus.</li></ul>

Continuous Improvement Manager

Department: Human Resources Job Title: Human Resources Manager Reports to: CEO The Role: The HR Manager leads a team handling all HR activities within the manufacturing facility and all related functions with particular focus on ensuring that a pro-active and strong employee relations culture exists and is continually cultivated. Responsibilities: <ul><li>Provides leadership and direction to a small and agile Human Resources team, including effective mentoring and training.</li><li>Day-to-day Human Resources support for all Irish-based employees.</li><li>Responsible for ensuring that systems and processes for payroll, healthcare, pension, bonuses and other benefits support accurate provision to colleagues and appropriate governance</li><li>In conjunction with management colleagues, ensures that the organisation promotes and practices a culture of open, fair and progressive employee engagement and relations on site.</li><li>Partners closely with senior, middle and front-line management to ensure a consistent approach to people management and related issues, advising on issues as they arise.</li><li>Developing plans for learning and development for colleagues across the business and promoting the comoany as a place to start and grow careers at all levels.</li><li>Works with management to initiate and maintain effective policies & practices that enables the attraction & retention of staff at all levels within the manufacturing facility.</li><li>Acts as sensor of potential employee relations issues and proactively works with management to address same and to address grievance, disciplinary and other matters in a timely and consistent manner.</li><li>Acts as the lead in helping to fill open vacancies within the production team.</li><li>Builds strong relationships with HR practitioners in the community to ensure access to best practices and other industry & functional trends and initiatives.</li><li>Ensures that the necessary HR processes & policies are in place and effectively communicated to all employees.</li><li>Works closely with the Manufacturing Operations Manager, Director of Manufacturing and the CEO to ensure a regular cascade of communication exists across the site. Acts as a key confidante on potentially sensitive people management issues.</li><li>Acts a key member of the overall HR team continually helping to build the profile of the function as an effective & efficient business partner.</li><li>Keeps up to date on any changes in Labour legislation and ensure related policies are updated and fit for purpose.</li><li>Partners with senior management to support organisational design, workforce planning, and leadership development.</li><li>Drives performance management, succession planning and talent development.</li></ul> The Person/Qualification: <ul><li>A proven track record of working as Senior HR Generalist or HR Manager in an manufacturing organisation.</li><li>Minimum of 5 years appropriate experience in a senior HR role in a fast-moving environment.</li><li>A proven track record in relationship building, strong communication and influencing skills.</li><li>Is approachable, demonstrates sensitivity, empathy and integrity.</li><li>A self-starter who can apply their own initiative in most situations.</li><li>A capacity to make sound judgements, seeking advice & counsel from others where required.</li><li>Is highly confidential and effectively able to deal with sensitive & difficult situations while remaining calm.</li><li>Ability to act as an ambassador for the company in promoting it as a great place to work.</li><li>Strong knowledge of Irish employment law and HR best practices.</li></ul> This job description is intended to provide a general overview of the responsibilities and requirements for the position. For full job specification and a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes.

HR Manager

Head of Manufacturing We are seeking an ambitious and driven professional to lead within a fast-paced manufacturing environment. As a key member of the management team, you will play a vital role in optimizing operational efficiency across key manufacturing services. Key Responsibilities: <ul><li>Production Management: Oversee molding and Surface Mount Assembly operations, ensuring efficient resource allocation and alignment with business objectives.</li><li>Quality & Process Improvement: Implement quality control measures, monitor production outputs, and drive continuous improvement initiatives.</li><li>Cost & Efficiency Management: Control production costs, optimize workflows, and enhance productivity.</li><li>Team Leadership & Development: Hire, train, and manage technical staff while fostering a strong team culture.</li><li>Health, Safety & Sustainability: Enforce safety standards and lead sustainability initiatives, including ISO50001 compliance.</li><li>Technology Integration: Stay ahead of industry advancements, implementing automation and new technologies to enhance operations.</li></ul>Requirements: <ul><li>7+ years of operational experience, ideally in a manufacturing environment.</li><li>Degree in Engineering (Mechanical, Production, or related field) or equivalent.</li><li>Proven leadership in managing technical teams and driving business strategies.</li><li>Strong analytical, problem-solving, and communication skills.</li></ul>This role offers a unique opportunity to shape manufacturing operations and contribute to long-term business success.

Head of Manufacturing

Manufacturing Engineer  Key Responsibilities:<ul><li>Report all health and safety incidents and near misses.</li><li>Perform risk assessments to identify hazards and implement mitigation strategies.</li><li>Investigate incidents and near misses to determine root causes and take corrective action.</li><li>Conduct routine safety audits and inspections to maintain a safe working environment</li><li>Delegate maintenance tasks and oversee technician workloads.</li><li>Foster a strong safety culture within the maintenance team.</li><li>Collaborate with technicians and engineers to reduce downtime through an escalation process.</li><li>Communicate critical downtime events to engineering and production teams.</li><li>Uphold 5S standards to ensure a clean and organized work environment.</li></ul>Education & Experience<ul><li>Bachelor’s degree in Engineering or a related field with a minimum of 3 years' relevant experience, or</li><li>Trade qualification with 5+ years of engineering experience.</li><li>Strong analytical, problem-solving, and data analysis skills.</li></ul> For a confidential conversation about the role contact Karl on +353 86 201 1223 or klippett@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Manufacturing Engineer

Quality Director   Overview:   <ul><li>Quality Director will be responsible for developing, overseeing, and advancing the company’s quality assurance strategy.</li><li>This leadership role ensures that all products and processes meet the highest standards of quality, safety, and regulatory compliance.</li><li>The successful candidate will champion a culture of continuous improvement, lead cross-functional quality initiatives, and play a critical role in maintaining customer satisfaction and operational excellence.</li></ul>  Key Responsibilities:   <ul><li>Identify quality-related risks and implement proactive mitigation strategies.</li><li>Collaborate with procurement and operations to monitor and improve supplier quality.</li><li>Lead implementation of continuous improvement initiatives, such as Lean and Six Sigma methodologies.</li><li>Oversee robust quality control systems, including testing protocols for raw materials, in-process inspections, and finished goods.</li><li>Establish and uphold quality standards, processes, and best practices across all departments.</li></ul>  Qualifications & Experience:   <ul><li>Bachelor’s degree in Engineering, Quality Management, or a related field (Master’s degree preferred).</li><li>Significant leadership experience in senior quality roles within manufacturing or regulated environments.</li><li>Deep knowledge of Quality Management Systems (QMS), ISO standards, and industry regulations.</li><li>Proven leadership skills with the ability to build, lead, and develop high-performing teams.</li></ul>  For a confidential conversation about the role contact Karl on +353 86 201 1223 or klippett@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Quality Director

Quality Engineer   Overview:   <ul><li>The Quality Engineer – Customer Quality plays a key role in overseeing product and process quality, while leading root-cause analysis and continuous improvement initiatives across production and support departments.</li><li>This position focuses on reducing non-conformances, driving compliance with quality standards, and executing quality improvement projects to enhance both customer satisfaction and operational efficiency.</li></ul>  Key Responsibilities:   <ul><li>Lead cross-functional problem-solving efforts, implementing effective Corrective and Preventive Actions (CAPA)</li><li>Ensure compliance with IATF 16949 and other relevant Quality Management System standards</li><li>Conduct internal QMS audits to evaluate compliance and identify improvement areas</li><li>Continuously improve the customer claim process to increase efficiency and satisfaction</li></ul>  Qualifications & Experience:   <ul><li>Degree in Engineering or a related Quality discipline</li><li>A proactive mindset focused on identifying risks and driving process improvement</li><li>Lean Six Sigma Green Belt certification (or higher) is advantageous</li><li>Previous experience in customer-facing quality roles is preferred</li></ul>  For a confidential conversation about the role contact Karl on +353 86 201 1223 or klippett@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Quality Engineer

Test Technician   Key Responsibilities:   <ul><li>Assist with the calibration of test and measurement equipment as needed.</li><li>The Test Technician will perform initial troubleshooting to diagnose and resolve mechanical, electrical, electronic, and pneumatic faults, escalating to second-level support when necessary.</li><li>Comprehensive training, support, and guidance will be provided. This role operates on a two-shift rotation patter</li><li>Troubleshoot technical faults promptly, delivering fast response times and effective resolutions.</li><li>Provide hands-on technical support to production areas, ensuring minimal downtime and optimal performance.</li></ul>  Qualifications & Experience:   <ul><li>Demonstrated training or experience in electronics and/or electrical systems is required.</li><li>Ability to read and interpret electrical drawings and schematics is essential.</li><li>Comfortable performing occasional manual labor.</li><li>Ability to work independently as well as collaboratively within a team.</li><li>Proficient in the use of hand and power tool</li></ul>  For a confidential conversation about the role contact Karl on +353 86 201 1223 or klippett@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Test Technician

The Role:  As a Customer Care Representative at our clients location in Galway, this role will support customer service, project management, and account management teams as well as playing a crucial role in the order management process by ensuring timely order processing, confirming realistic delivery times through the careful application and following established processes and procedures. In doing so, the CCR will work closely with cross functional teams at our European headquarters Responsibilities:  <ul><li>Ensure timely and accurate order processing while coordinating with operations and planning to provide realistic delivery timelines.</li><li>Act as a point of contact for both internal and external customers, handling inquiries, order updates, complaints, and sample requests with professionalism and efficiency.</li><li>Work closely with cross-functional teams including operations, engineering, and planning to resolve issues and improve service delivery.</li><li>Apply pricing and surcharges in line with company policies to ensure consistency and revenue integrity.</li><li>Track and oversee customer orders throughout the production process, communicating potential delays and offering alternative solutions when necessary.</li><li>Assist the Regional Manager in managing key accounts and participating in business reviews to enhance customer satisfaction and long-term partnerships</li></ul> Requirements:  <ul><li>Education and Experience: Bachelor's degree in a commercial field or related discipline. Minimum of 2 years relevant work experience in customer service, sales or account management, or equivalent combination of education and experience. </li><li>Experience with CRM and ERP systems. Knowledge and experience in SAP & Microsoft Dynamics is a plus.</li><li>Customer focused & relationship management: The CCR can respond to changing customer needs and develop and strengthen partnerships. Along with the ability to deal with various interpersonal styles.</li><li>Teamwork: The CCR work both independently and with (cross-functional) teams in Galway and Venray. In addition to maintaining relationships within the team, collaborate effectively to gather information, make decisions and suggest improvements.</li><li>Communication skills: Excellent oral and written communication skills in English.</li><li>Careful and structured: A keen eye for detail, but also have an overview of the bigger picture, able to prioritize tasks based on urgency.</li><li>Willing to travel to companies Headquarters abroad every 4-6 weeks for training purposes. </li></ul> For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Customer Care Representative

QUALITY ENGINEER (DAYS)   Job Summary: To ensure that products manufactured at the site complies with approved specifications and that activities at the site comply with current good manufacturing practice and Regulatory Agency requirements. To work as a member of the Quality Team to ensure that Quality goals and objectives are achieved. Ensure that all actions comply with current good manufacturing practice.   Key Responsibilities: <ul><li>Coordinating appropriate assigned elements of the Quality System, ensuring full compliance by all relevant plant personnel with its requirements.</li><li>Audit the quality system with other personnel where required.</li><li>Assist in the investigation and coordination of customer complaints and assess the need for implementation of effective corrective or preventive actions.</li><li>Manage day-to-day CAPA requirements by ensuring timely and effective initiation, investigation, correction and corrective actions.</li><li>Measure performance of the Quality System and provide metrics, for inclusion in the management review, monthly reports etc.</li><li>Ensure all plant personnel are fully aware of quality requirements (where relevant) by providing the necessary training.</li><li>Ensure Management is kept informed of all system failures to ensure corrective/preventive action and product containment is taken where necessary.</li><li>Verification of effectiveness of corrective/preventive actions arising out of product process and quality system non-compliance.</li><li>Ensure implementation and compliance with relevant Regulator requirements.</li><li>Assist in the performance of validation activities at the site.</li><li>Ensure Quality System documentation is thorough, complete, and compliant.</li><li>Ensure compliance with training requirements is maintained.</li><li>Review lot records, ensuring documentation is compliant with requirements and completing lot release for shipment.</li><li>Inspect incoming products and manage the supplier Quality relationship.</li><li>Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems at the site.</li><li>Complete in-process and final release product testing per the relevant approved specifications and procedures.</li><li>Where required. Review batch records, ensuring documentation is compliant with requirements.</li><li>Complete disposition decision for the batch.</li><li>Participate in Risk Management activities as required.</li></ul>  Essential Requirements  <ul><li>Degree in an Engineering, Science, Quality or other discipline</li></ul>  Desired Requirements  <ul><li>A Green Belt qualified or demonstrated knowledge of statistics in an industrial environment is desirable.</li></ul> Experience Required <ul><li>2 years plus experience in the day-to-day operation of the quality system in a highly regulated combination product/device manufacturing environment.</li><li>Minimum 2 years working knowledge of quality systems regulations (ISO13485/ISO9000; CFR 21 Part 820) or individual elements within the regulations such as process validation, design controls, CAPA, auditing, etc., is desirable.</li><li>Experience in an injection moulding or tooling environment is desirable.</li></ul>  For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

The Role:  The successful candidate will be responsible for designing, coding, and testing DeltaV software changes identified during all stages of the project lifecycle as well as working with a range of other automation related systems such as PLC and DCS systems and others. You will contribute to technical strategy for the execution of Automated projects and review all work during the design, commissioning, and validations stages.   Skills Brief <ul><li>Significant experience working with DeltaV distributed controls systems</li><li>You should have Emerson Process Management DeltaV Platform experience as well as knowledge and experience in Batch Processing</li><li>Ideally you will have been trained in the Emerson inhouse DeltaV training house</li><li>At least 5 years’ experience with Automation systems administration, knowledge in one or more of the following systems, Rockwell Factory Talk, DCS, OSI PI Historian, Syncade, Siemens is essential.</li><li>Knowledge of S88</li><li>Demonstrated proficiency communicating and collaborating at a variety of levels, coupled with excellent organization and planning skills</li><li>In addition to problem solving, project management ability is essential</li><li>Ability to work independently and remotely with minimum direct supervision</li><li>Strong Customer relationship management skills</li><li>Strong Critical thinking skills</li></ul> Requirements/Qualification:  <ul><li>Candidates must have a B.Sc. degree in Engineering or equivalent, with emphasis in software development, electrical, electronic or automation discipline, with a minimum of 5 years’ experience in industry, preferably in a pharmaceutical, biotechnology, blue chip or relevant GMP manufacturing environment.</li><li>The ideal candidate will have excellent communication skills and strong problem skills.</li><li>Candidates trained in house on DeltaV with Emersons dedicated DeltaV training center will be given preference.</li></ul> For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Delta V Engineer

The Role:  We are currenrly partnering with a Sligo based pharmaceutical client who is actively seeking a Process Equipment Engineer to join their facility. This is an initial 12 month contract role.  Responsibilities: <ul><li>To work as a team member to support engineering in pharma operations in line with all safety, regulatory and organizational requirements.</li><li>Develop and modify procedures as needed to support the manufacturing operation.</li><li>Participate in process, equipment, and facilities validations efforts and projects implementations.</li><li>Process and equipment engineering Subject Matter Expert for a vial filling and isolator equipment from design phase to equipment handover.</li><li>Review, and approve process flow diagrams (PFDs), specifications, layouts and P&ID’s. Interface with vendor to ensure that equipment/facility designs are aligned and to ensure efficient transfer of information between vendor and site.</li><li>Review vendor design documentation to ensure compliance with process and technical specifications.</li><li>Lead the FAT and SAT activities ensuring the equipment is design, fabricated and tested to meet the technical requirements of the project.</li><li>Support foller equipment installation integration and co-ordinate vendor supervision as required.</li><li>Support the development of the project commissioning and validation plan.</li><li>Develop commissioning plans for all process related equipment ensuring that plans meet the requirements of Good Engineering Practice (GEP)</li><li>Review all process related validation protocols for completeness and accuracy.</li><li>Execute protocols in a timely basis to meet the project schedule requirements.</li><li>Participating in design and process project conversations to ensure reliability by design is built in prior to equipment arrival.</li><li>Leadership of manufacturing and validation activities during project life cycle.</li><li>Support of technical transfers for future product introductions to the site.</li><li>Assesses and owns the relationship between process requirements and unit operation equipment.</li><li>Understands the impact of equipment control systems on processing performance Investigate process exceptions or equipment malfunction incidents affecting the process.</li><li>Liaising with operations, quality and S&T to ensure equipment and process performance is maximized.</li><li>To liaise with Internal/External Engineering Personnel and contract maintenance providers in maintaining trouble shooting and installing/commissioning equipment.</li><li>Implementation of equipment/process upgrade in an environment of continuous improvement.</li><li>Support the Production Team in ensuring that manufacturing equipment is maintained to meet the output and yield requirements.</li><li>Adhering to all relevant policies relating to Quality & Safety.</li><li>Ensure successful external inspections, and Division and Corporate audits.</li><li>Supervision of external contractors.</li></ul>   Requirements: <ul><li>A relevant third level qualification in an engineering, science or technical discipline (Degree Level or Masters Preferable)</li><li>At least six (5) years of total combined experience in Process / Equipment or Manufacturing Engineering of a Pharmaceutical and Health Care Organization.</li><li>At least three (3) years of experience in the manufacturing environment of a biotechnology, pharmaceutical or health care plant.</li><li>Previous experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, and sterilization operations preferable.</li><li>Experience in new product introductions (drug product) to pharmaceutical facilities is desirable.</li></ul> For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Process Equipment Engineer

We are currentely partnering with a Dundalk based client who is actively recruiting for a Junion Cyner security & infrustructure engineer Responsibilities:  1. Carry out all cyber security, infrastructure engineering and related issues including but not limited to: · System Administration: <ul><li>Install, configure, and maintain hardware, software, and network systems</li><li>Monitor system performance and ensure optimal operation</li><li>Manage user accounts and permissions</li></ul> · Network Management: <ul><li>Design, implement, and manage network infrastructure</li><li>Monitor network performance and troubleshoot issuesEnsure network security through firewalls, VPN’s and other security measures</li></ul> · Technical Support: <ul><li>Provide technical support to end users for hardware, software, and network issues</li><li>Resolve technical problems either remotely or on-site</li><li>Document support processes and resolutions</li></ul> · Security: <ul><li>Implement and maintain security protocols to protect data and systems</li><li>Conduct regular security audits and vulnerability assessments</li><li>Stay updated with the latest security threats and mitigation techniques</li></ul> · Backup and Recovery: <ul><li>Develop and implement data backup and recovery plans</li><li>Ensure regular backups are performed and data integrity is maintained</li><li>Manage disaster recovery plans and procedures</li></ul> · Project Management: <ul><li>Plan and manage IT projects, including upgrades and new implementations</li><li>Coordinate with other departments to understand their IT needs and provide solutions</li><li>Ensure projects are completed on time and within budget</li></ul> · Documentation: <ul><li>Maintain comprehensive documentation of systems, configurations, procedures, and changes.</li><li>Create user manuals and technical documentation for IT processes</li></ul> · Accreditation: <ul><li>Accreditation can be obtained through various professional organisations, educational institutions, and certification bodies</li></ul> · Onboarding: <ul><li>Internal onboarding and new starter set up</li></ul> 2. Carry out duties in such a manner as to comply with the Health & Safety Policy of the company, including: <ul><li>Taking reasonable care for your own safety & that of others</li><li>Arriving for work free from any intoxicant</li><li>Wearing Personal Protective Equipment where applicable</li><li>Not engaging in improper conduct or behaviour</li><li>Reporting known defects</li><li>Not intentionally or recklessly interfering with or misuse equipment</li><li>Participating in health & safety training provided</li></ul> 3. Assist with on-the-job training and development of staff as required 4. Take appropriate action to maintain or improve relationships with all customers 5. You are required to use your best endeavours to promote the best interests of the Company and abide by the rules, policies and procedures of the Company Requirement:  <ul><li>Basic Knowledge of Networking and IT Infrastructure</li><li>Familiarity with Cyber Security Concepts</li><li>Experience with Operating Systems (Linux/Windows)</li><li>Basic Scripting or Automation Skills</li></ul> For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Junior Cyber Security

Quality Director Overview: We are seeking a Quality Director to lead our client's quality strategy, ensuring compliance, optimizing processes, and fostering continuous improvement. Key Responsibilities: <ul><li>Develop and implement quality standards, methodologies, and best practices.</li><li>Ensure regulatory compliance (e.g., ISO) and manage audits.</li><li>Oversee quality control systems and performance monitoring.</li><li>Drive process improvements using Lean, Six Sigma, and other methodologies.</li><li>Manage supplier quality and conduct supplier audits.</li><li>Lead and develop a high-performing quality team.</li><li>Identify risks, implement mitigation strategies, and enhance customer satisfaction.</li></ul> Qualifications & Experience: <ul><li>Education: Bachelor’s degree in Engineering, Quality Management, or related field (Master’s preferred).</li><li>Experience: Senior quality leadership experience, preferably in a regulated manufacturing environment.</li><li>Certifications: CQM, Six Sigma (Green/Black Belt), or CQA preferred.</li><li>Skills: Strong leadership, analytical, and problem-solving abilities.</li></ul>

Job Summary Reporting to the Financial Controller, the primary function of the Financial Accountant is to assume responsibility for the preparation and presentation of reconciled financial statements within the Finance Department and direct daily activities in accordance with Company policies. Key Responsibilities: <ul><li>Preparation with Finance team of Month end close, Journal entries and Forecast financial statements</li><li>Responsible for ensuring full reconciliation of month end balance sheet in accordance to strict reporting deadlines</li><li>Working closely with GBS (Shared Service Centre) on the management of the plant accounts</li><li>Preparation of statutory financial statements, Revenue returns and other external reporting</li><li>Liaison with internal and external auditors</li><li>Development of and adherence to Corporate best practice policies and procedures supporting compliance to Sarbanes Oxley initiatives</li><li>Initiate and implement process improvement activities to meet business objectives</li><li>Detailed plant performance analysis and measurement against KPI’s</li><li>Work closely with Finance team to complete activities of the accounting department</li></ul> Qualifications / Experience: <ul><li>Qualified ACA, ACCA, CIMA, CPA or Business (Hons) equivalent</li><li>3 year’s plus, post qualification experience</li><li>Suit a person wanting to move from practice into industry or a person currently working in industry, looking to move to a US Global publicly quoted Manufacturing company</li><li>Strong financial accounting and costing experience</li><li>Experience of implementing/testing internal controls</li><li>Excellent PC skills – Accounting packages (SAP preferred), Microsoft Office</li><li>Excellent analytical skills</li><li>Excellent organizational skills, working to tight reporting deadlines</li><li>Proactive, self-starter and results/goals orientated</li><li>Strong interpersonal skills with the ability to communicate effectively</li></ul>

Financial Accountant

The role:  To coordinate the development and maintenance of the site validation program and ensure the site and external regulatory, quality, and compliance requirements are met. Coordination, implementation and active participation in the site Validation Program and general Quality Assurance activities.   Responsibilities:  <ul><li>Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.</li><li>Generation/maintenance/execution of the Site Validation Master Plan.</li><li>Generation/maintenance/execution of Project Validation Plans and schedules.</li><li>Generation of validation protocols and final reports to cGMP standards.</li><li>Generation of validation investigations and implementation of corrective actions.</li><li>Creation/Review/Approval of various quality documents and test data.</li><li>Management of validation, exception event, and change control processes.</li><li>Maintenance and tracking of validation equipment, if applicable.</li><li>Completing all required training before executing a task.</li><li>Documenting all activities in line with cGMP requirements.</li><li>Updating of validation procedures, job instructions and batch documentation to reflect current best practices.</li><li>Performing cross training within the team and training of new team members.</li><li>Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.</li><li>Coordinating activities to maximize the effectiveness of all of the team members.</li><li>Maintaining the overall cGMP compliance of the production areas.</li><li>Communicating with peers and management regarding activities in the area, including elevation of events or concerns.</li></ul> Essential Requirements/Experience <ul><li>Qualification and/or degree in engineering or scientific discipline.</li><li>3 years plus of knowledge of cGMP, validation and regulatory requirements relating to the biopharmaceutical industry.</li><li>Strong communication (written and oral), presentation and troubleshooting skills required</li><li>Effective interpersonal and organizational skills.</li><li>Ability to work well both independently and in a team environment.</li><li>Capable of prioritizing work and multitasking.</li></ul>  For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes.

QA Validation Engineer

Purpose: The reliability engineer will champion continuous improvement to reduce the levels of risk to the business for both equipment and utility related issues on site and ensure engineering compliance with requirements. Support the maintenance excellence program by targeting critical equipment assets for optimization and continuous improvement.     Responsibilities: <ul><li>Support the engineers with the next level of MEP to fully integrate MEP into the culture.</li><li>Implement programs and procedures required to ensure equipment maintenance is performed in a compliant manner</li><li>Monitor the operation of equipment and systems.</li><li>Track, analyse and improve key Maintenance Excellence Program (MEP) key performance indicators (KPI’s) parameters such as asset utilization, maintenance cost, site maintenance compliance, schedule etc.</li><li>Apply knowledge in methods and processes to prevent, or reduce, the likelihood or frequency of failures in site systems.</li><li>Determine the use of predictive maintenance technologies.</li><li>Conduct root cause failure analysis (RCFA) Reliability-Centred Maintenance (RCM) Failure Mode Effects Analysis (FMEA),Fault tree analysis (FTA), PM optimisation.</li><li>Train employees on reliability processes, trains supervision on the impact that the operators and technicians have on reliability.</li><li>Reviews completed work orders, assists planners with reliability concerns, promotes preventive maintenance as ongoing experiments and champions the technicians through continuous education.</li><li>Analyse failure history to determine the reliability characteristics of systems, and from this analysis develop long term solutions to re-occurring issues.</li><li>Review maintenance and installation plans for new equipment, provide reliability and maintainability specifications for new procurements. Is involved in developing support plans for new equipment.</li><li>Demonstrate commitment towards achieving department targets.</li><li>Perform internal audits on engineering systems, support external audits.</li><li>Ensure adherence to company safety standards, policies and procedures.</li><li>Proficient in the use of Computer Management Maintenance system (Maximo).</li><li>Manage the Engineering Change Control process to ensure there are no non-conformances relating to engineering change control.</li><li>Participate constructively as a member of the dept, keeping everyone informed and proactively share knowledge and expertise within the team.</li></ul>     Qualifications/Requirements: <ul><li>A third level qualification in Engineering or a relevant discipline coupled with 3 years relevant work experience</li></ul> OR  <ul><li>Trade qualification plus six years plus engineering experience</li></ul> <ul><li>Strong IT Skills are required for this position.</li><li>Requires proven problem solving skills under the pressure. The position requires detailed evaluation of a number of viable solutions to each problem.  </li><li>Requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis.</li><li>Requires a very high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times.</li><li>Must be results driven striving to meet all targets and metric standards as set by site/department and division leaders.</li><li>Requires total commitment to quality and maintaining a high standard of work at all times.</li><li>Demonstrates the highest levels of integrity and a strong work ethic at all times.</li><li>Strong communication skills both verbal and written are required for the execution of this role.</li><li>Strong interpersonal skills are required.</li><li>Understands and Supports the principles of Perfect Performance.</li><li> </li></ul>

Reliability Engineer

The Project Engineer is responsible for the development, planning, execution, and engineering support of capital and expense project plans related to the implementation, installation, commissioning and qualification of new, and upgrades to existing, facilities, utilities, manufacturing and packaging equipment. The role provides project engineering to project teams, contractors, and support staff and ensures project activities are well-coordinated, controlled, and executed as planned, in full compliance with all applicable standards, SOPs, Company guidelines, and regulatory agency codes and regulations. The Project Engineer coordinates execution efforts with operations, facilities, equipment maintenance, EHS, laboratory, development, materials management and quality assurance personnel to minimize impact of project activities on existing facility and production operations.   Responsibilities: <ul><li>Perform process and equipment reviews, prepare technical reports detailing equipment operation and best practices, and recommend new equipment or process changes that will result in quality improvement or cost reduction.</li><li>Develop user requirement specifications, technical specifications and design specifications for replacement equipment or upgrades to existing equipment and select correct design concepts and the fundamental technology to be used for new equipment or improvement of existing equipment.</li><li>Manage the execution of the project plan, including change control management, coordinating project activities of the department and other internal and external resources, and monitoring and reporting project status and cost.</li><li>Develop plan for equipment qualification.</li><li>Author and execute equipment qualification protocols (IQ OQ).</li><li>Support and adhere to established processes and productivity targets.</li><li>Observe established escalation process for issues impacting established production-related Service Level Agreements (SLAs) and/or fulfillment of production goals.</li><li>Recognize and report to immediate supervisor any issues or deviations from accepted standards.</li><li>Provide status updates on own activities and productivity challenges according to defined procedures.</li><li>Complete and conform to all training requirements for job role, including company-required and job role-specific training.</li><li>Observe all safety and compliance procedures and actively highlight any safety concerns to help drive the reduction of accidents or near misses.</li><li>May participate in department initiatives and projects.</li><li>May require travel for equipment selection and FAT’s.</li></ul>   Requirements: <ul><li>Bachelors Degree in Engineering or equivalent combination of education and work experiences required.</li><li>3-5 years related experience and nor training; or equivalent combination of education and experience.</li><li>Experience in pharmaceutical manufacturing and packaging equipment and/or pharmaceutical processing equipment design, evaluation, and specification is an advantage.</li><li>Detailed understanding of P&IDs, process flow diagrams, and all related pharmaceutical commissioning and qualification documentation.</li><li>Experience working with pharmaceutical processing technologies and good understanding of 2ICFR cGMP documentation and electronic systems requirements.</li><li>Demonstrated experience applying sound engineering principals and critical reasoning to troubleshoot complex process and engineering challenges.</li><li>Proficiency of computer skills with Microsoft Word, Excel, Outlook, CAD.</li></ul> For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes.

Project Engineer

The MES Engineer will be responsible for maintaining the MES (POMSnet) environment, including authoring and managing recipes and worksheets for our clients site. The role involves providing technical guidance and solutions to other MES Engineers, acting as the site escalation point for complex troubleshooting or recipe design, and offering project management expertise to the MES function. Responsibilities: <ul><li>Design, create, write and/or make all required changes to MES Recipes, worksheets, equipment and material spec's including phase transition logic</li><li>Design, create, write and execute, test and validation protocols, risk assessments, and system documentation.</li><li>Design, create, write and/or make all required changes to ensure cleaning, equipment and product procedures are aligned to MES processes and vice versa.</li><li>Design, create, write and provide training for all other site personnel on their related MES roles and arrange system access.</li><li>Participate in MES knowledge exchanges, MES Governance meetings, and manage issues, work-arounds and fixes identified.</li><li>Liaise with Global MES on Westport required system improvements.</li><li>Provide support to other MES system users as required to ensure business continuity.</li><li>Participate in NPI projects from initiation to ensure MES system or hardware requirements are taken into consideration.</li><li>Keep other recipe authors up to date on MES changes</li><li>Documentation of all activities in line with cGMP requirements.</li><li>Cross training within the team and training of new team members.</li><li>Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems.</li><li>Adheres to and supports all EHS standards, procedures and policies.</li></ul> Requirements/Qualificaton: <ul><li>Third Level qualification in suitable manufacturing, engineering or business course and/or suitable experience.</li><li>A minimum of 7 years authoring experience and has led or was technical lead on multiple implementation projects.</li><li>Be proficient with MES application and configuration rules and requirements including interfacing (preferably POMSnet).</li><li>Experience of batch processing operations in an FDA/HPRA regulated industry. Strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry.</li><li>A good knowledge of IT systems is required for this role.</li><li>SAP knowledge/experience in MM, PP and IM modules.</li><li>Proven attention to detail and mental concentration, to always ensure total compliance with procedures.</li></ul> For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Senior MES Engineer

Quality Manager – Limerick Key Responsibilities: <ul><li>Develop and implement a Quality Management System (QMS) to meet customer expectations.</li><li>Lead and mentor the quality team, fostering a culture of improvement.</li><li>Support quality control processes (Incoming, In-Process, Final) and CAPA initiatives.</li><li>Conduct audits, complaint investigations, and ensure compliance with ISO & BRC standards.</li><li>Optimize processes using 8D reporting, 7-step problem-solving, and risk assessments.</li><li>Manage supplier quality, performance, and approvals.</li><li>Maintain quality documentation and report key metrics to management.</li><li>Develop training programs to enhance quality awareness.</li></ul> Requirements: <ul><li>Degree in Science, Engineering, or related field.</li><li>Knowledge of SPC, Cpk, validation, and statistics (MiniTab preferred).</li><li>Experience with GMP, TPM, and Quality Systems.</li><li>Strong leadership, problem-solving, and communication skills.</li><li>Proficiency in Microsoft Office.</li></ul>

Quality Manager

We are currently recruiting on the behalf of our clieny for a Toolmaker who will work as a member of the toolroom team delivering Production ready blow moulds and fixtures to the Production Department.   Key responsibilities: <ul><li>Precision machining of component parts, tools and fixture</li><li>Program and operate CNC and manual machine tools</li><li>Repair and maintain blow moulds and ancillary equipment</li><li>Fit an assemble parts to make, repair or modify dies, jigs, gauges and tools using machine and hand tools</li><li>Ensure that work completed consistently meets design specification and highest engineering and quality standards</li><li>Participate in continuous improvement activities, new product introduction projects and troubleshooting problems in production</li><li>Ensure that health and safety standards are fully adhered to at all times</li></ul> Requirements  <ul><li>The successful candidate will be a Qualified Toolmaker with problem solving capability.</li><li>Ability to program and operate CNC machines is essential</li><li>They should be highly motivated with the ability to work on own initiative and to deadlines.</li></ul> For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes.

Senior Toolmaker

Job Summary Our client is currenlty hiring for a Senior Process Engineer to assist the Engineering/Production department in improving the manufacturing of product and develop the most optimum molding process and tooling and automation that meets or exceeds customer requirements on both new and existing tooling. This person will provide the company with the technical resources to ensure that current and future projects are run in accordance with customer specifications and in-house specifications and standards. Requirements <ul><li>Must have a minimum of a National Diploma in Plastics Engineering (Preferably a Degree in Plastics Engineering) and at least 4-5 years’ experience in the injection molding industry.</li><li>Must have a very good knowledge of Injection mold tooling and design.</li><li>Must have a very good knowledge of Injection Molding (standard process and Multi component), Processing, Ancillary equipment and automation systems.</li><li>Preferably worked in either the Medical, Packaging or technological industries.</li><li>Preferably have some knowledge of Real time monitoring systems.</li><li>Must have an in-depth knowledge of Statistical Process Control (SPC) and Design of experiments (DOE) and demonstrate use of same.</li><li>Should have a good knowledge of the principles of WCM, JIT, SMED, and Kaizen.</li><li>Must have knowledge in computer systems; integrated manufacturing systems; word processing and spreadsheets. (Also, knowledge of MFG Pro would be a distinct advantage).</li><li>Must have excellent written and verbal communication skills as well as the ability to accurately document work performed.</li><li>Must be able to work in a fast-paced environment.</li><li>Must be able to travel as required by the position.</li><li>Must be able to work independently on own projects while working concurrently with all departments.</li></ul> Essential Job Duties and Responsibilities <ul><li>Responsible for the introduction of all new products into the company and compiling standard specifications for each process and monitoring all existing production to standard specifications.</li><li>Ensures process optimization using statistical techniques.</li><li>Works with the Production Group leaders (PGL’s) in troubleshooting processing problems.</li><li>Establishes relationships with the customers and Equipment/ Raw Material suppliers in pursuit of continuous improvement and on-going business development.</li><li>Solves, in conjunction with the Quality department, customer related problems/issues as needed</li><li>Instructs others, formally or informally, regarding manufacturing related skills or knowledge and assist in the training of employees on new processes or systems introduced to the company.</li><li>Coordinate the development of documentation in the Production and Technical areas in line with ISO9001:2000 and ISO 13485 requirements and review the systems with the Group Leaders and the Quality department on a regular basis to ensure conformance to same.</li><li>Communicate on a regular basis (or as appropriate) with external suppliers of materials and equipment and provide regular feedback on any issues to the management team.</li><li>Perform additional duties at the request of the direct supervisor.</li></ul> For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes.

Senior Process Engineer

The role We have a current opportunity for a Plastic Process Technician on a permanent basis with our client based in Longford. The Technician is responsible for, tool changes, monitoring and adjusting machine parameters, testing batch quality, and reporting equipment malfunctions. Responsibilities:  <ul><li>A Polymer Processing Technician is responsible for the setup of the toolHave a strong technical aptitude of processing characteristics and parameters for a broad range of polymer materials</li><li>Required to work with Production Manager, Technical Manager, Shift Manger, Team Leaders, Quality and Toolroom personnel</li><li>Self-motivate.</li><li>Maintain company & product reputation by complying with all necessary Quality & Safety regulations</li><li>Willingness to work 4 -cycle shift system</li></ul> Qualifications & Key Attributes <ul><li>Applicants must have obtained a minimum of 5 O6 grades in their Leaving Cert</li><li>Completed a Polymer Technology Apprenticeship qualification or equivalent qualification</li><li>Experience 2 years</li></ul> For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes.

Plastic Process Technician

Our client is a leader in industrial automation, renowned for delivering cutting-edge solutions to industries worldwide. They specialize in innovative technologies and systems that optimize manufacturing processes and enhance productivity. Joining their team means being part of a forward-thinking organization at the forefront of automation technology. Electrical Design Engineer Responsibilities: <ul><li>Design and develop electrical systems for automation machinery.</li><li>Prepare schematics, wiring diagrams, and panel layouts using ECAD tools.</li><li>Select appropriate electrical components to meet project specifications.</li><li>Ensure compliance with electrical safety standards and regulations.</li><li>Collaborate with other engineering disciplines to integrate electrical designs into overall systems.</li><li>Provide technical support during installation and commissioning phases.</li></ul>Requirements: <ul><li>Bachelor’s degree in Electrical Engineering or related field.</li><li>3+ years of experience in electrical design for industrial or automation applications.</li><li>Proficiency in ECAD software (EPLAN, AutoCAD Electrical, or similar).</li><li>Strong knowledge of PLCs, HMIs, and motor control systems.</li><li>Familiarity with relevant standards (e.g., IEC, NEC).</li></ul>

Electrical Design Engineer

Continuous Improvement Engineer – Medical Device Location: Limerick, Ireland Type: Permanent We are seeking a highly motivated Continuous Improvement (CI) Engineer to join a leading medical device company in Limerick. This is a permanent role designed for a results-driven professional passionate about driving efficiency, innovation, and excellence within manufacturing and operational processes. Responsibilities <ul><li>Lean Process Optimization: Identify and implement lean manufacturing techniques to optimize processes, reduce waste, and improve productivity.</li><li>Data-Driven Improvements: Utilize data analysis tools to monitor performance, identify trends, and implement data-driven solutions.</li><li>Project Management: Lead and support cross-functional projects focused on improving manufacturing processes, quality, and operational efficiency.</li><li>Kaizen and Six Sigma: Facilitate continuous improvement initiatives, including Kaizen events and Six Sigma projects, ensuring measurable outcomes.</li><li>Training and Development: Provide coaching and training to employees on lean principles, Six Sigma methodologies, and continuous improvement tools.</li><li>Problem-Solving: Investigate root causes of process inefficiencies or defects using structured problem-solving methods and implement corrective actions.</li><li>Stakeholder Engagement: Collaborate with production, quality, and supply chain teams to align improvement initiatives with business objectives.</li><li>Regulatory Compliance: Ensure all process improvements comply with industry standards and regulatory requirements (e.g., ISO 13485, FDA).</li><li>Documentation: Maintain detailed records of process changes, validations, and outcomes to support traceability and compliance.</li></ul> Requirements <ul><li>Experience:<ul><li>3+ years of experience in continuous improvement or process engineering roles, preferably in the medical device, pharmaceutical, or manufacturing industry.</li><li>Hands-on experience with lean tools and Six Sigma methodologies.</li></ul></li><li>Education:<ul><li>Bachelor’s degree in engineering, manufacturing, or a related field.</li><li>Lean Six Sigma certification (Green Belt or Black Belt) is highly desirable.</li></ul></li><li>Skills:<ul><li>Strong analytical skills with the ability to interpret data and drive actionable insights.</li><li>Proficiency in CI tools such as Value Stream Mapping, DMAIC, and Root Cause Analysis.</li><li>Excellent organizational, communication, and leadership skills.</li><li>Proactive mindset with a passion for driving change and innovation.</li><li>Team-oriented and able to build relationships across multiple departments.</li><li>Detail-oriented with a commitment to delivering high-quality results.</li></ul></li></ul> By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes. For more information and a confidential chat please contact Gerard Cunniffe on +353 86 190 8885.

Continuous Improvement Engineer

Project Engineer – Medical Device Location: Limerick Type: Permanent We are seeking a dynamic and detail-oriented Project Engineer to join a leading medical device company. This permanent role is ideal for a proactive professional with strong project management skills and technical expertise in a regulated industry. The successful candidate will play a critical role in ensuring the successful execution of engineering projects while maintaining compliance with industry standards. Responsibilities<ul><li>Project Management: Plan, execute, and manage engineering projects from initiation to completion, ensuring adherence to scope, schedule, and budget.</li><li>Technical Oversight: Provide technical input and support for the design, development, and implementation of new processes and equipment.</li><li>Cross-Functional Collaboration: Work closely with R&D, manufacturing, quality, and supply chain teams to ensure seamless project integration.</li><li>Equipment and Process Validation: Oversee equipment installation, commissioning, and validation (IQ, OQ, PQ) in compliance with regulatory requirements.</li><li>Documentation: Develop and maintain detailed project documentation, including plans, schedules, risk assessments, and progress reports.</li><li>Regulatory Compliance: Ensure all projects comply with relevant standards and regulations, such as ISO 13485 and FDA requirements.</li><li>Risk Management: Identify project risks and implement mitigation strategies to minimise impact.</li><li>Supplier Coordination: Collaborate with external vendors and suppliers to source and validate materials, equipment, or services.</li><li>Continuous Improvement: Identify opportunities to enhance processes, reduce costs, and improve efficiency within project scopes.</li></ul> Requirements<ul><li>Experience:<ul><li>3+ years of experience in project engineering, preferably in the medical device or pharmaceutical industry.</li><li>Proven ability to manage multiple projects simultaneously in a regulated environment.</li></ul></li><li>Education:<ul><li>Bachelor’s degree in engineering (mechanical, biomedical, or related discipline).</li><li>Project management certification (e.g., PMP, PRINCE2) is advantageous.</li></ul></li><li>Skills:<ul><li>Strong understanding of engineering principles and manufacturing processes.</li><li>Proficiency in project management tools and software (e.g., MS Project, Smartsheet).</li><li>Experience with equipment and process validation.</li><li>Excellent communication and interpersonal skills.</li><li>Strong analytical and problem-solving capabilities.</li><li>Highly organised with the ability to manage competing priorities effectively.</li></ul></li></ul> By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes. For more information and a confidential chat please contact Gerard Cunniffe on +353 86 190 8885.

Manufacturing Engineer – Medical Device Location: Limerick, Ireland Type: Permanent We are hiring a skilled Manufacturing Engineer to join a leading medical device company in Limerick. This permanent role is ideal for a results-driven professional passionate about optimizing manufacturing processes, ensuring product quality, and driving innovation in a regulated environment. Responsibilities<ul><li>Process Optimization: Develop, implement, and improve manufacturing processes to enhance efficiency, quality, and scalability.</li><li>Equipment Management: Oversee the installation, validation, and maintenance of manufacturing equipment, ensuring optimal performance.</li><li>Problem-Solving: Troubleshoot production issues, identify root causes, and implement effective corrective actions.</li><li>Continuous Improvement: Collaborate with cross-functional teams to identify opportunities for process improvement and cost reduction.</li><li>Regulatory Compliance: Ensure all manufacturing processes comply with relevant regulatory standards, such as ISO 13485 and FDA requirements.</li><li>Documentation: Create and maintain detailed process documentation, including work instructions, process flow diagrams, and validation reports.</li><li>New Product Introduction (NPI): Support the introduction of new products by developing and validating manufacturing processes and equipment.</li><li>Training and Support: Provide technical support and training to production staff to ensure consistent adherence to processes and quality standards.</li><li>Data Analysis: Monitor production data to identify trends, analyze performance metrics, and recommend improvements.</li></ul> Requirements<ul><li>Experience:<ul><li>3+ years of experience in manufacturing engineering, preferably in the medical device or pharmaceutical industry.</li><li>Proven track record of working with automated and manual assembly processes.</li></ul></li><li>Education:<ul><li>Bachelor’s degree in manufacturing engineering, mechanical engineering, or a related field.</li></ul></li><li>Skills:<ul><li>Strong understanding of lean manufacturing principles and Six Sigma methodologies.</li><li>Experience with equipment validation (IQ, OQ, PQ) and process validation.</li><li>Proficiency in CAD software and manufacturing systems (e.g., ERP, MES).</li><li>Strong communication and interpersonal skills for cross-functional collaboration.</li><li>Detail-oriented and capable of managing multiple projects in a fast-paced environment.</li></ul></li></ul> By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes. For more information and a confidential chat please contact Gerard Cunniffe on +353 86 190 8885.

Senior Manufacturing Engineer

Project Manager – Packaging (Medical Device) Location: Dublin, Ireland Type: Long-term Contract We are seeking an experienced Project Manager with packaging expertise to join our client, a leading medical device company in Dublin. This is a long-term contract role, ideal for a highly motivated professional with a proven track record in managing packaging-related projects within regulated industries such as medical devices or pharmaceuticals. Responsibilities <ul><li>Project Leadership: Lead and manage end-to-end packaging projects, ensuring alignment with client goals and regulatory standards.</li><li>Packaging Development: Oversee the design, testing, and implementation of packaging solutions for medical devices.</li><li>Cross-Functional Collaboration: Work closely with R&D, manufacturing, quality assurance, and supply chain teams to ensure seamless project execution.</li><li>Regulatory Compliance: Ensure all packaging solutions meet relevant regulatory requirements (e.g., ISO 11607, FDA standards).</li><li>Risk Management: Identify project risks, develop mitigation strategies, and implement solutions proactively.</li><li>Budget and Timeline Management: Track project budgets, maintain schedules, and deliver milestones on time and within scope.</li><li>Vendor Management: Liaise with external suppliers and vendors to source and manage packaging materials and services.</li><li>Continuous Improvement: Drive innovation and process improvements in packaging methodologies and materials.</li></ul> Requirements <ul><li>Experience:<ul><li>Minimum 5 years of project management experience in packaging, preferably in the medical device or pharmaceutical industry.</li><li>Strong knowledge of packaging materials, design processes, and validation protocols.</li></ul></li><li>Education:<ul><li>Bachelor’s degree in engineering, packaging science, project management, or a related field. PMP certification is a plus.</li></ul></li></ul> By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes. For more information and a confidential chat please contact Gerard Cunniffe on +353 86 190 8885.

Project Manager

Job Title: CQV Lead Engineer Location: Galway, Ireland Contract: 12-Month Fixed Term Job & Company Overview: Our client is a global leader in Medical Device Manufacturing working to transform how people manage their health. They are seeking a highly motivated and skilled CQV Lead Engineer to support the setup and validation of their new Greenfield manufacturing facility in Athenry. This is a 12-month contract role that will play a critical part in ensuring the successful construction, commissioning, and qualification of all facility, utility, and equipment systems. This position involves two key phases: 1. Construction & Commissioning Oversight – Managing and coordinating Construction Complete, Turnover, and Mechanical Completion through Commissioning in collaboration with the General Contractor (GC). 2. Qualification Execution – Generating, executing, and approving Qualification documents for Direct Impact Systems (Facility, Utility, and Equipment). Key Responsibilities: • Lead and coordinate Construction Completion, Turnover, and Mechanical Completion activities. • Oversee commissioning of all systems with the General Contractor (GC). • Develop, execute, and approve IQ, OQ, PQ qualification protocols for direct impact systems. • Work closely with cross-functional teams, including Engineering, Quality, and Operations, to ensure compliance with regulatory requirements. • Identify and resolve commissioning and qualification challenges to maintain project timelines. • Ensure adherence to GMP, FDA, ISO 13485, and other relevant regulations. • Maintain detailed documentation of all CQV activities. Requirements: • Proven experience in CQV (Commissioning, Qualification, and Validation) within Medical Device or Pharmaceutical industries. • Strong track record in large-scale campus delivery of greenfield projects. • Expertise in Facility, Utility, and Equipment Qualification. • Knowledge of cGMP, FDA, ISO 13485, and industry best practices. • Strong project management and stakeholder coordination skills. • Ability to problem-solve and drive tasks to completion in a fast-paced environment. By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes. For more information and a confidential chat please contact Gerard Cunniffe on 086 190 8885 or gcunniffe@sterlingengineeringeu.com

CQV Lead Engineer

Senior Automation Engineer – Tuam, Co. Galway Overview: We are seeking an experienced Senior Automation Engineer to join our team in Tuam, Co. Galway. This role offers an exciting opportunity to work in a cutting-edge manufacturing environment, driving automation solutions to enhance efficiency, reliability, and quality in a high-tech production facility. Key Responsibilities: <ul><li>Lead the design, development, and implementation of automation solutions for manufacturing processes.</li><li>Troubleshoot, maintain, and optimize PLC, SCADA, and robotic systems to ensure smooth operation.</li><li>Work closely with cross-functional teams, including production, maintenance, and quality, to drive continuous improvement initiatives.</li><li>Develop and maintain technical documentation, including system specifications, validation protocols, and troubleshooting guides.</li><li>Support commissioning and validation of new automated systems and equipment.</li><li>Ensure compliance with industry standards, safety regulations, and company policies.</li><li>Provide technical leadership and mentorship to junior engineers and technicians.</li><li>Identify opportunities for process optimization and drive automation projects from concept to completion.</li><li>Collaborate with external vendors and integrators to implement best-in-class automation technologies.</li></ul> Requirements: <ul><li>Degree in Automation Engineering, Electrical Engineering, Mechatronics, or a related field.</li><li>Minimum 5+ years of experience in automation engineering within a manufacturing environment.</li><li>Strong knowledge of PLC programming (Siemens, Allen Bradley, etc.), SCADA systems, and industrial robotics.</li><li>Experience with vision systems, sensors, and industrial networks (e.g., Ethernet/IP, Profibus, etc.).</li><li>Understanding of GMP, FDA, and other regulatory requirements (preferred but not essential).</li><li>Excellent problem-solving skills with the ability to work independently and as part of a team.</li><li>Strong project management skills with experience in delivering automation projects on time and within budget.</li><li>Excellent communication and interpersonal skills.</li></ul> If you are an experienced automation professional looking for a challenging and rewarding role, we would love to hear from you! By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes. For more information and a confidential chat please contact Gerard Cunniffe on 086 190 8885 or gcunniffe@sterlingengineeringeu.com

Controls Automation Engineer

Manufacturing Project Engineer (12-Month Contract) Location: County Cork, Ireland Company Overview:  A leading global medical device company based in County Cork is seeking a Manufacturing Project Engineer on a 12-month contract. The role will focus on supporting regulatory compliance, validation, change control, and project execution in a fast-paced manufacturing environment. Key Responsibilities: <ul><li>Regulatory Compliance: Ensure adherence to medical device regulations (ISO 13485, FDA, MDR) in manufacturing processes.</li><li>Validation: Lead and execute validation activities (IQ/OQ/PQ) for equipment, processes, and systems.</li><li>Change Control: Oversee and support change control processes, ensuring proper documentation and approval.</li><li>Project Execution: Assist in managing project tasks, timelines, and deliverables, working with cross-functional teams.</li><li>Documentation: Maintain clear documentation for validation, change control, and project progress.</li></ul> Required Skills and Experience: <ul><li>3+ years of experience in medical device manufacturing, including regulatory compliance and validation.</li><li>Strong knowledge of FDA, ISO 13485, and EU MDR regulations.</li><li>Experience in change control processes and project task execution.</li><li>Excellent attention to detail, communication, and problem-solving skills.</li><li>Ability to work in a cross-functional team and manage multiple priorities.</li></ul> Contract Duration: 12 months, with potential for extension. By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes. For more information and a confidential chat please contact Gerard Cunniffe on 086 190 8885 or gcunniffe@sterlingengineeringeu.com

Position: Manufacturing / NPI Engineer Location: Galway Our Client is a growth-stage medical device company based in Galway and are currently recruiting for a Manufacturing / NPI Engineer. As a Manufacturing Engineer / NPI Engineer, you will play a vital role within the multidisciplinary engineering team. You will contribute to technology advancement projects, including developing new manufacturing processes, refining device concepts, and validating innovative technologies and methods. Duties: <ul><li>Development of new methods of device manufacture</li><li>Rapidly prototype product and fixture concepts in-house - using standard catheter building equipment and techniques such as 3D printing.</li><li>Modelling and analysis of mechanical systems using SolidWorks or similar software</li><li>Work with medical device polymers within a catheter manufacturing environment</li><li>Conceive, develop and improve manufacturing processes for proof-of-concept, verification and validation testing</li><li>Design, build and document novel neurovascular catheter-based technology</li><li>Support and manage efforts to verify and validate new product designs</li><li>Identify and interact with vendors to obtain engineering materials, processes, and equipment</li></ul> Experience: <ul><li>Degree in Engineering</li><li>Minimum of 2 years’ experience in the medical device industry</li><li>Demonstrated ability to rapidly prototype product and fixture concepts using standard equipment and techniques such as 3D printing</li><li>Modelling and analysis of mechanical systems using SolidWorks or similar</li><li>Experience of working with medical device polymers</li><li>Strong aptitude for process verification and validation, process development and implementation</li><li>Commitment to ongoing personal development to improve technical and non-technical skillsets</li></ul> By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes. For more information and a confidential chat please contact Gerard Cunniffe on 086 190 8885 or gcunniffe@sterlingengineeringeu.com

NPI / Manufacturing Engineer

Job Title: Senior Electrical Engineer Location: Cork Employment Type: Full-Time - Hybrid Option About the Role: We are seeking a highly skilled Senior Electrical Engineer to join our clients team and contribute to a variety of electrical projects in the Microelectronics and Pharmaceutical sectors. This role offers an exciting opportunity to work on cutting-edge projects, ensuring the successful design, development, and implementation of electrical systems in high-tech environments. Key Responsibilities: <ul><li>Lead the design and implementation of electrical systems for Microelectronics and Pharmaceutical projects.</li><li>Develop electrical schematics, layouts, and specifications in compliance with industry standards and project requirements.</li><li>Conduct power system studies, including load flow analysis, short circuit analysis, and protection coordination.</li><li>Collaborate with multidisciplinary teams, including mechanical, process, and automation engineers, to ensure seamless integration of electrical systems.</li><li>Ensure compliance with relevant electrical codes, standards, and safety regulations.</li><li>Provide technical guidance and mentorship to junior engineers and project teams.</li><li>Support procurement activities by preparing specifications and evaluating vendor proposals.</li><li>Oversee and support the installation, commissioning, and testing of electrical systems.</li><li>Conduct site inspections and provide technical support during project execution.</li><li>Troubleshoot and resolve electrical design and construction issues efficiently.</li></ul> Qualifications & Experience: <ul><li>Bachelor's or Master’s degree in Electrical Engineering or a related discipline.</li><li>Minimum of 5 years of experience in electrical engineering, preferably within the Microelectronics and Pharmaceutical industries.</li><li>Strong understanding of electrical design, power distribution, and control systems.</li><li>Proficiency in using electrical design software such as AutoCAD, Revit, ETAP, or similar tools.</li><li>Experience with industry standards and regulations, such as IEC, NEC, and local building codes.</li><li>Proven ability to manage projects and work effectively within a team.</li><li>Strong analytical and problem-solving skills.</li><li>Excellent communication and interpersonal skills.</li><li>Willingness to travel to project sites as required.</li></ul> By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes. For more information and a confidential chat please contact Gerard Cunniffe on +353 86 190 8885.

Senior Electrical Engineer

Our client is a leader in industrial automation, renowned for delivering cutting-edge solutions to industries worldwide. They specialize in innovative technologies and systems that optimize manufacturing processes and enhance productivity. Joining their team means being part of a forward-thinking organization at the forefront of automation technology. Controls Automation Engineer Responsibilities: <ul><li>Develop and program control systems for automation equipment.</li><li>Configure PLCs, HMIs, and SCADA systems.</li><li>Conduct system testing, debugging, and troubleshooting.</li><li>Integrate electrical and mechanical systems into cohesive automation solutions.</li><li>Provide technical support during installation and commissioning.</li></ul>Requirements: <ul><li>Bachelor’s degree in Automation Engineering, Electrical Engineering, or a related field.</li><li>3+ years of experience in controls automation engineering.</li><li>Proficiency in programming PLCs (Siemens, Allen-Bradley, etc.).</li><li>Familiarity with industrial communication protocols (Ethernet/IP, Profibus, etc.).</li><li>Strong analytical and problem-solving skills.</li></ul>

Electrical Engineer Join our Automation team to design and deliver innovative Electrical Design Solutions for bespoke automated assembly machines used in production. Collaborate with Mechanical Design and Controls Teams, contributing from concept design to commissioning and validation of electrical systems. Key Responsibilities: Design and develop electrical solutions and schematics for automated assembly machines. Evaluate and select electrical components; maintain accurate BOMs. Manage electrical builds in collaboration with suppliers and partners. Provide technical support through design, build, debug, and commissioning phases. Conduct electrical design reviews and contribute to risk and safety assessments. Create and maintain documentation for new and upgraded equipment. Requirements: Experience with Eplan or SolidWorks Electrical. Knowledge of electrical systems, safety circuits, PLCs, industrial networks, vision systems, robotics, and motion control. Strong problem-solving, time management, and attention to detail. Excellent communication skills; team-oriented. Qualifications: Level 8 in Electrical/Electronic Engineering or equivalent; or Qualified Electrician with relevant experience. 3+ years in a similar role. By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes. For more information and a confidential chat please contact Tommy McKeown on +35386 2044918/ tmckeown@sterlingengineeringeu.com

Electrical Engineer 

Our client is a leader in industrial automation, renowned for delivering cutting-edge solutions to industries worldwide. They specialize in innovative technologies and systems that optimize manufacturing processes and enhance productivity. Joining their team means being part of a forward-thinking organization at the forefront of automation technology. Mechanical Design Engineer Responsibilities: <ul><li>Design and develop mechanical systems and components for automation projects.</li><li>Create detailed 3D models and engineering drawings using CAD software.</li><li>Perform stress and tolerance analyses on mechanical designs.</li><li>Collaborate with cross-functional teams to ensure designs meet project requirements.</li><li>Assist in prototyping and testing new mechanical solutions.</li><li>Maintain documentation for design modifications and improvements.</li></ul>Requirements: <ul><li>Bachelor’s degree in Mechanical Engineering or related field.</li><li>3+ years of experience in mechanical design, preferably in automation or manufacturing.</li><li>Proficiency in CAD software (SolidWorks, AutoCAD, or similar).</li><li>Knowledge of materials and manufacturing processes.</li><li>Strong problem-solving skills and attention to detail.</li></ul>

Mechanical Design Engineer

We are currently working with a Leitrim based client who is actively recruitng for a Process Engineer to join their manufacturing plant. Reporting to the Moulding Production Manager, the primary function of this role is to assume responsibility for the control and management of all process driven systems within the Injection Moulding department and direct daily activities in accordance with Company policies. Responsibilities: <ul><li>New tool debug, set up and validation</li><li>Process optimisation using DOE and Statistical Methodology</li><li>Responsible for control of overall quality, process capability, and associated documentation</li><li>Troubleshooting of process, equipment and systems problems using sound engineering principles and data driven decisions</li><li>Provide training and support to Production Technicians</li><li>Root cause analysis and corrective action implementation</li></ul> Qualifications/Requirements:  <ul><li>Degree level qualification in Polymer Science or another relevant Engineering discipline and/or proven equivalent experience</li><li>Strong communication and teamwork skills are essential for this role</li><li>Sound analytical, troubleshooting and problem-solving skills</li><li>Proficient in using a variety of moulding machine types and associated ancillary equipment</li></ul> For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Moulding Process Engineer

Engineering Project Manager Role Overview: <ul><li>Reporting to the Group Engineering Manager, the Engineering Project Manager will take a proactive approach to managing engineering projects across the group, ensuring their delivery on time, within budget, and to the highest standards. </li></ul>Main Duties: <ul><li>Project Management: Lead and deliver various engineering projects, ensuring timely and cost-effective completion.</li><li>Stakeholder Communication: Collaborate with all stakeholders to provide regular updates on project progress and promptly address any issues that arise.</li><li>Problem Solving: Analyze engineering challenges by gathering information, conducting research, and recommending solutions. Tasks may include preparing drawings, schematics, and diagrams; evaluating components, materials, and suppliers; developing specifications and safety standards; and overseeing equipment installations.</li><li>Team Coordination: Organize and manage internal teams and third-party contractors to execute projects efficiently while ensuring adherence to project plans throughout the lifecycle.</li><li>Project Reporting: Maintain team achievements by sharing essential information, coordinating actions, resolving open issues, and contributing to team meetings and reports.</li><li>Cross-Site Collaboration: Work closely with group sites to implement projects efficiently, minimizing disruption to production processes.</li><li>Supplier Management: Source and negotiate with suppliers, monitor parts delivery, and ensure swift actioning of received items.</li><li>Budgeting and Cost Analysis: Assist with engineering budget preparation and conduct cost evaluations to ensure financial efficiency.</li></ul>Key Competencies<ul><li>Strong analytical and troubleshooting/problem-solving skills.</li><li>Excellent verbal and written communication abilities.</li><li>High technical aptitude with meticulous attention to detail.</li><li>Proficient in IT tools, including Excel and AutoCAD (essential).</li><li>Strong organizational skills, with the ability to manage conflicting priorities effectively.</li><li>A team player with enthusiasm, flexibility, and a commitment to high standards for self and others.</li><li>Self-motivated and capable of working under pressure and on own initiative.</li><li>A focus on continuous improvement and a drive to enhance existing processes.</li><li>Adaptability and a positive approach to change.</li><li>Willingness to travel as required.</li></ul>Experience and Qualifications<ul><li>Degree or Diploma in Electrical/Mechanical Engineering (or equivalent).</li><li>Proven experience in project management.</li><li>Extensive industry experience in a similar role.</li><li>Strong mechanical and electrical knowledge of equipment and processes.</li><li>Prior experience in water treatment or automation (preferred but not essential).</li></ul> For a confidential conversation about the role contact Karl at +353 86 201 1223 or klippett@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Engineering Project Manager

Head of Manufacturing We are seeking an ambitious and driven professional to lead within a fast-paced manufacturing environment. As a key member of the management team, you will play a vital role in optimizing operational efficiency across key manufacturing services. Key Responsibilities: <ul><li>Production Management: Oversee molding and Surface Mount Assembly operations, ensuring efficient resource allocation and alignment with business objectives.</li><li>Quality & Process Improvement: Implement quality control measures, monitor production outputs, and drive continuous improvement initiatives.</li><li>Cost & Efficiency Management: Control production costs, optimize workflows, and enhance productivity.</li><li>Team Leadership & Development: Hire, train, and manage technical staff while fostering a strong team culture.</li><li>Health, Safety & Sustainability: Enforce safety standards and lead sustainability initiatives, including ISO50001 compliance.</li><li>Technology Integration: Stay ahead of industry advancements, implementing automation and new technologies to enhance operations.</li></ul>Requirements: <ul><li>7+ years of operational experience, ideally in a manufacturing environment.</li><li>Degree in Engineering (Mechanical, Production, or related field) or equivalent.</li><li>Proven leadership in managing technical teams and driving business strategies.</li><li>Strong analytical, problem-solving, and communication skills.</li></ul>This role offers a unique opportunity to shape manufacturing operations and contribute to long-term business success.

This is a unique opportunity to be part of a rapidly growing global Group with an exciting future ahead. As a key member of the Finance team, you will help to maintain and develop the financial and cost accounting systems for the Group, liaising closely with colleagues and other stakeholders locally and across subsidiary companies. Responsibilities: <ul><li>Collecting and analysing data on the company’s operational costs</li><li>Monitor variances to standard cost and investigate differences.</li><li>Drive consistency and standardisation of cost accounting</li><li>Carrying out margin analysis,</li><li>Management, development and maintenance of the financial systems to meet the changing requirements of the organisation, while ensuring the development of procedures for these systems</li><li>Review current interfaces and propose solutions to streamline and reduce manual intervention</li><li>Performing account reconciliations</li><li>Preparing audit reports and presenting their findings to management</li><li>Support finance projects and process improvements.</li><li>Liaise with external auditors and other professional advisors, as required.</li><li>Other, as needed.</li></ul> Knowledge, skills, and experience: <ul><li>Qualified Accountant (ACA, ACCA, CIMA, CPA)</li><li>Relevant hands-on experience.</li><li>Excellent IT and systems experience; advanced excel and PowerBI</li><li>Excellent analytical and data management skills.</li><li>Excellent planning and organisational skills.</li><li>Strong interpersonal skills, a good communicator, both written and verbal.</li><li>A strong commercial acumen and attention to detail.</li></ul> Personal attributes: <ul><li>High degree of integrity, objectivity, and professionalism.</li><li>Open and curious, takes initiative, solution oriented.</li><li>Flexible, able to manage challenging and often competing deadlines.</li><li>Collaborative, a team player.</li><li>Motivated, energised, and committed to timely delivery.</li><li>A focus on continued development.</li></ul> For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes.

Cost Accountant

We have a current opportunity for a Biologics Engineering Technician - Ballytivnan on a contract basis. The position will be based in Sligo.    Responsibilities: <ul><li>To work as a team member to support engineering in pharma operations in line with all safety, regulatory and organizational requirements.</li><li>Participating in design and process project conversations to ensure reliability by design is built in prior to equipment arrival.</li><li>Owning and preparing, preventative and predictive maintenance for new pharma equipment being installed and approval of these procedures on Maximo.</li><li>Completion and documentation of PM’s and pDM’s on manufacturing equipment in to Maximo.</li><li>Owning and ensuring that commissioning spare parts are received and cataloged in Maximo.</li><li>Owning and ensuring that critical spare parts are identified and once received, cataloged in Maximo.</li><li>Active Participation in Factory Acceptance testing, Site Acceptance Testing and commissioning and qualification of equipment.</li><li>Review and approve process related commissioning, qualification and validation protocols for completeness and accuracy. Execute protocols in a timely basis to meet the project schedule requirements</li><li>Review and approve process flow diagrams (PFDs), specifications, layouts and P&ID’s.  Ensuring proactive high performance of day to day preventative and demand maintenance activity to maintain manufacturing and utility equipment.</li><li>Liasing with operations, quality and technical operations to ensure equipment and process performance is maximized.</li><li>To maintain records and documentation on relevant Engineering Procedures and preventative/ demand maintenance.</li><li>To liaise with Internal/External Engineering Personnel and contract maintenance providers in maintaining troubleshooting, and installing/commissioning equipment.</li><li>Completion of instrument calibration as per schedule.</li><li>Take ownership of the site’s Predictive Maintenance program, through managing and developing the outsourced condition monitoring contracts, implementing recommendations, and tracking to closure.</li><li>Implementation of equipment/process upgrade in an environment of continuous improvement.</li><li>Support the Production Team in ensuring that manufacturing equipment is maintained to meet the output and yield requirements.</li><li>Adhering to all relevant policies relating to Quality & Safety.</li><li>Ensure successful external inspections, and Division and Corporate audits.</li><li>Supervision of external contractors.</li></ul>   Requirements: <ul><li>Relevant Trade Qualification or engineering qualification to Cert level at a minimum (Diploma/Degree Preferred)</li><li>Minimum of 5 years in a highly regulated manufacturing (Pharma/Biologics/Medical Device) environment required</li><li>Proven problem solving ability on complex equipment</li><li>Proven instrumentation/PLC troubleshooting ability</li></ul>  This role has 20% shift (days/evenings rotating on a weekly basis) - Days: 07:00 – 15:30 Monday to Thursday, 14:30 finish Friday - Evenings: 15:00 – 23:30 Monday to Thursday; 14:00 – 21:20 on Friday   For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes.

Biologics Engineering Technician

Senior Production Planner   Key Responsibilities:   <ul><li>Oversee manufacturing operations, collaborating with Manufacturing Engineering, Project Management, and other teams to develop, prioritize, and maintain the Master Production Schedule.</li><li>Implement and optimize production build scheduling to ensure efficiency.</li><li>Ensure the availability of materials, labor, and resources to meet production schedules and delivery commitments.</li><li>Manage forecasting and demand planning for multiple projects.</li><li>Maintain and manage MRP systems, including work order creation, pick and pack lists, and production & quality documentation.</li><li>Support Purchasing, Materials Handling, Stores, and Logistics teams, optimizing procurement processes.</li><li>Liaise with suppliers and logistics providers to resolve supply chain issues.</li><li>Ensure inventory accuracy and proper record maintenance.</li><li>Coordinate and manage Engineering Changes (ECN) and New Product Introduction (NPI).</li><li>Promote a continuous improvement mindset, driving lean and efficiency initiatives.</li><li>Assist in the implementation and development of ERP systems.</li><li>Ensure Environmental Health & Safety (EHS) compliance, adhering to all EHS regulations and procedures.</li><li>Provide regular production and material status updates to the wider team and report on Key Performance Indicators (KPIs).</li></ul>  Qualifications & Skills:   <ul><li>6+ years of experience in Production Planning or a related field.</li><li>Strong experience in ERP systems and MRP management.</li><li>Excellent communication skills with high attention to detail.</li><li>Strong organizational and planning abilities.</li><li>Ability to manage multiple projects in a fast-paced environment.</li></ul>  Desirable:   <ul><li>Experience in purchasing and logistics management.</li><li>Background in life sciences or medical devices.</li><li>Experience with electronic and electromechanical products.</li><li>Strong customer-facing skills.</li><li>Ability to provide cross-departmental support when needed.</li></ul>  For a confidential conversation about the role contact Karl on +353 86 201 1223 or klippett@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Senior Production Planner

Vendor Engineer   Key Responsibilities:   <ul><li>Drive the onsite supplier audit program in collaboration with the Quality Department.</li><li>Assess and onboard new suppliers as part of the supplier evaluation team.</li><li>Develop and implement a supplier rating system based on department KPIs.</li><li>Ensure Supply Chain policies and procedures are kept up to date.</li><li>Represent the Supply Chain team in customer and standards certification audits.</li><li>Participate in value analysis programs to enhance efficiency and cost-effectiveness.</li><li>Contribute to achieving Supply Chain KPIs, including dual sourcing, cost reduction, and supplier management.</li></ul>  Qualifications & Experience:   <ul><li>Third-level degree in Supply Chain, Engineering, or Quality.</li><li>Auditing experience (e.g., ISO 9001, ISO 14001, ISO 45001) is an advantage.</li><li>5+ years of experience in a supply chain or technical role.</li><li>Strong time management, task prioritization, project management, and leadership skills.</li></ul>  For a confidential conversation about the role contact Karl on +353 86 201 1223 or klippett@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Vendor Engineer

Senior Business Analyst   <ul><li>We are looking for an experienced Senior Business Analyst to lead an exciting project at our manufacturing facility in Limerick. This role will focus on assessing and designing a replacement for the legacy "Scan to ERP" solution.</li><li>The successful candidate will evaluate upgrade requirements and deliver a high-level design, cost estimate, resourcing plan, and timeline.</li><li>Additionally, this role will provide general business analysis support to the Limerick site and potentially other regional locations.</li></ul>  Key Responsibilities:   <ul><li>Lead the assessment and preliminary design phase for the "Scan to ERP" replacement project.</li><li>Work closely with stakeholders to define requirements, deliverables, cost estimates, resourcing plans, and timelines.</li><li>Document and analyze current business processes (as-is) and propose optimized future-state processes (to-be).</li><li>Elicit, document, and validate business and technical requirements.</li><li>Recommend process and system improvements to enhance efficiency and outcomes.</li><li>Serve as the primary liaison between business stakeholders, senior management, and IT teams.</li><li>Ensure clear communication to align goals and expectations.</li><li>Engage with subject matter experts (SMEs) across systems, technology, and processes to drive project success.</li></ul>  Qualifications & Skills:   <ul><li>Proven experience as a Senior Business Analyst, working closely with senior management and cross-functional teams.</li><li>Background in manufacturing or distribution is essential.</li><li>Experience in the life sciences industry is a plus.</li><li>Technical Expertise:</li><li>Familiarity with ERP systems, particularly legacy technologies (e.g., AS400-based solutions).</li><li>Knowledge of RFgen mobile barcoding and data collection technology is desirable.</li><li>Strong functional understanding of ERP platforms in a manufacturing environment is preferred.</li></ul>    For a confidential conversation about the role contact Karl on +353 86 201 1223 or klippett@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Senior Business Analyst

RF Engineer   <ul><li>As an RF Engineer, you will be responsible for designing, testing, and implementing Radio Frequency (RF) systems and devices that align with company and customer requirements.</li><li>This role involves a blend of RF system design, hands-on lab measurements, tuning, and testing both on the bench and in our RF Anechoic Chamber.</li><li>Additionally, you will support approvals testing in external labs. Collaboration with hardware and software engineers is essential to ensure seamless RF system integration while meeting performance and regulatory standards.</li></ul>  Key Responsibilities:   <ul><li>Design and develop RF systems and components, including antennas, filters, and amplifiers.</li><li>Conduct impedance matching, harmonic measurement, filtering, antenna tuning, polar plotting, and range testing.</li><li>Develop and execute test procedures to ensure compliance with performance and regulatory standards (e.g., RED, EMC).</li><li>Stay up to date with emerging RF technologies, industry trends, and advancements.</li><li>Collaborate with cross-functional teams to ensure timely project completion, while maintaining and updating technical documentation.</li><li>Additional Requirements:</li><li>Solid understanding of wireless communication protocols, including Sub-1GHz, BLE, WiFi, and cellular technologies such as 5G and LTE.</li></ul>  Education & Experience:   <ul><li>Bachelor’s degree in Electronics, Computer Networks, Microwave, or Telecommunications Engineering (preferred).</li><li>3+ years of experience in RF engineering.</li><li>Strong proficiency with RF design tools and laboratory equipment, including Spectrum Analyzers, Vector Network Analyzers, Oscilloscopes, and Signal Generators.</li></ul>  For a confidential conversation about the role contact Karl on +353 86 201 1223 or klippett@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

RF Engineer

Injection Mould Design Engineer In line with company growth, we are seeking a new Injection Mould Design Engineer to join our clients expanding team. Roles and Responsibilities <ul><li>Design and develop multi-cavity injection mould tools tailored for the medical device industry.</li><li>Collaborate closely with clients and the manufacturing team to understand specifications and project requirements.</li><li>Oversea subcontracted work, making sure that the projects remain on track. Select appropriate materials and components to meet performance and regulatory standards.</li><li>Troubleshoot and resolve design challenges to achieve optimal performance and reliability.</li><li>Manage multiple projects, meeting deadlines and maintaining high-quality standards</li></ul> Qualifications, Experience and Skills <ul><li>Required Bachelor’s or Master’s degree in Mechanical Engineering, Design Engineering, or a related field.</li><li>Minimum of 5 years of experience in designing injection mould tools.</li><li>Prior experience in injection moulding and overmoulding Experience working in the medical device industry is desirable but not essential Proficiency in CAD software in specific Solidworks Excellent problem-solving and analytical skills. Excellent attention to detail and precision.</li><li>Effective communication skills and the ability to work collaboratively in a team environment and deal with customers directly Ability to manage time efficiently, prioritising tasks and working to deadlines.</li><li>Self-starter who is comfortable taking initiative Desire to work in an environment where integrity, respect, ownership and excellence are valued </li></ul> For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes.

Injection Mould Design Engineer

Quality Inspections Associate We are currently hiring for our Quality Inspections Team. Full training will also be provided to the right Candidate. YOU’LL GET THE CHANCE TO: <ul><li>Package products for shipping</li><li>Follow inspection procedures and maintain Good Manufacturing Practice & Good Document Practice</li><li>Perform visual, dimensional, and functional inspections on medical devices using a variety of equipment to ensure consistency</li><li>Document and report inspection findings and results</li><li>Appropriately identify and segregate non-conforming products</li><li>Inspect products prior to final release</li><li>General work area housekeeping</li><li>Support the training of new Quality Inspection Associates</li><li>All other duties as assigned</li></ul>WHAT WILL HELP YOU SUCCEED? Required: <ul><li>Excellent Attention to Detail</li><li>Good PC skills</li><li>Flexibility / ability to work shift</li><li>Strong communication skills</li><li>A self-starter with demonstrated efficient work methods, analytical & problem-solving skills and ability to handle multiple tasks in a fast-paced environment.</li></ul>Desired: <ul><li>Experience in a Quality/ Manufacturing Environment.</li></ul>

Job Summary:The Quality Technician will be responsible for supporting quality assurance activities in a medical device manufacturing environment. This role includes performing inspections, maintaining compliance with regulatory standards, and assisting with quality control processes to ensure product integrity and customer satisfaction. Key Responsibilities:<ul><li>Conduct in-process and final inspections of medical devices to ensure compliance with ISO 13485, FDA, and GMP regulations.</li><li>Support non-conformance investigations and assist in implementing corrective and preventive actions (CAPA).</li><li>Perform routine testing, documentation, and validation of quality control processes.</li><li>Assist in internal and external audits to ensure compliance with regulatory and company quality standards.</li><li>Maintain accurate records and documentation for quality assurance and traceability purposes.</li><li>Collaborate with manufacturing, engineering, and regulatory teams to improve product quality and processes.</li><li>Support calibration and maintenance of inspection equipment.</li><li>Provide training and guidance to production staff on quality standards and best practices.</li></ul>Required Qualifications & Skills:<ul><li>Diploma or Bachelor's degree in Engineering, Science, or a related technical field.</li><li>2+ years of experience in a quality-related role within the medical device industry.</li><li>Knowledge of ISO 13485, FDA, and GMP requirements.</li><li>Experience with inspection techniques, measurement tools, and documentation control.</li><li>Strong problem-solving and analytical skills.</li><li>Excellent attention to detail and ability to follow strict quality procedures.</li><li>Effective communication and teamwork skills.</li></ul>Preferred Qualifications:<ul><li>Experience with CAPA, NCRs, and validation processes.</li><li>Knowledge of statistical process control (SPC) and root cause analysis methodologies.</li><li>Familiarity with ERP/MES systems for quality data management.</li></ul>Work Environment:<ul><li>Manufacturing floor and laboratory-based work.</li><li>Requires attention to detail and adherence to cleanroom protocols.</li></ul>

Quality Technician

Job Summary:The Manufacturing Team Lead will be responsible for supervising daily manufacturing operations, ensuring production targets are met while maintaining high-quality and compliance standards. This role involves leading a team of operators, coordinating workflows, and driving continuous improvement in a medical device manufacturing environment. Key Responsibilities:<ul><li>Supervise and coordinate production activities to meet output, quality, and efficiency targets.</li><li>Ensure compliance with GMP, ISO 13485, and FDA regulations in all manufacturing processes.</li><li>Train, mentor, and develop production team members to enhance skills and performance.</li><li>Monitor production schedules and resource allocation to optimize efficiency.</li><li>Identify and resolve production issues, implementing corrective and preventive actions (CAPA).</li><li>Collaborate with cross-functional teams, including Quality, Engineering, and Supply Chain, to support manufacturing objectives.</li><li>Drive continuous improvement initiatives using Lean and Six Sigma methodologies.</li><li>Ensure workplace safety, enforcing compliance with health and safety regulations.</li><li>Maintain accurate documentation and reporting to support audits and regulatory compliance.</li></ul>Required Qualifications & Skills:<ul><li>Bachelor’s degree in Engineering, Manufacturing, or related field, or equivalent experience.</li><li>3+ years of experience in a manufacturing leadership role, preferably in the medical device industry.</li><li>Strong knowledge of GMP, ISO 13485, and FDA regulatory requirements.</li><li>Proven leadership and team management skills.</li><li>Experience with lean manufacturing and process improvement techniques.</li><li>Excellent problem-solving, organizational, and decision-making abilities.</li><li>Strong communication and interpersonal skills.</li></ul>Preferred Qualifications:<ul><li>Six Sigma or Lean Manufacturing certification.</li><li>Experience with ERP/MES systems in a manufacturing setting.</li><li>Familiarity with validation and process improvement methodologies.</li></ul>Work Environment:<ul><li>Manufacturing floor and office-based work.</li><li>Requires standing for extended periods and working in a controlled environment.</li><li>Occasional evening or weekend shifts may be required.</li></ul>

Manufacturing Team Lead

Senior Quality Engineer   PURPOSE OF THE JOB: The Senior Quality Engineer is a member of the Quality and Regulatory department and plays a key role in ensuring that the Quality Management System functions are maintained in compliance with documented procedures they support the QMS integration activity across the site providing guidance and expertise to ensure on-going compliance and continuous improvement alongside cost reduction. Will assist or supervise other Quality Engineers, technicians and/or administrative personnel in the performance of their duties. The position reports to the Senior Quality and Regulatory Manager and the role is based in Shannon, onsite 5 days per week, hiring with a view to develop the right candidate into a Quality Manager within 1 year.   RESPONSIBILITIES <ul><li>Stays current with external and internal quality systems standards and requirements.</li><li>Management of the Design Control Process from a Quality perspective and provide assistance and guidance to the Design and Development Team on all aspects of Design Control Documentation. FMEA, Quality Agreement, Quality Plan development.</li><li>Review and approve operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes. Protocol and Report, generation, approval.</li><li>Investigate complex product quality and compliance issues (e.g. CAPA, non-conformances, audit observations), analyse data, make recommendations and develop reports and present. Select appropriate techniques for problem solving and make solid and consistent Engineering and Quality Assurance recommendations. Applies problem-solving skills in order to deal creatively with complex situations. Identifies problems and possible solutions and takes appropriate action to resolve. (5 Whys, 8D, A3)</li><li>Identifies deficiencies in quality systems and defines systematic corrective actions. Supports the continuous improvement of quality system processes.</li><li>Develops effective quality metrics (KPIs) and communicates results to key stakeholders. PowerPoint ready.</li><li>Preparation and maintenance of records associated with the Management Review process.</li><li>Drives compliance cross functionally – mentors and guides other departments where necessary, updating and creating quality procedures through the change control process to support this.</li><li>Participate and support internal and external audits.</li><li>Train, coach and guide colleagues on all aspects of Quality Management System, Including own the Quality Induction process.</li><li>Assists sitewide with quality improvement programs by utilising Six Sigma tools and Lean techniques, including the education of facility personnel on these tools and techniques.</li><li>Assumes responsibility for various assigned projects designed to improve product quality, reduce costs and/or validate facility products or processes, including development and implementation of any new or required inspection methods and in-process SPC.</li><li>Deputise for Senior Quality and Regulatory Manager as requested or required. Performs other duties as assigned based on business needs</li></ul>  REQUIRED QUALIFICATIONS <ul><li>Excellent written and spoken English, spelling and grammar are key skills.</li><li>Bachelor’s degree in Quality/Engineering/Science– Masters degree an advantage.</li><li>Level 5 or above in training or similar.</li><li>Minimum 8-10 years of experience in medical device industry with 3 years of supervisory/leadership experience.</li><li>Competent working knowledge of recognized Quality Management Systems and Global Medical Device regulations (e.g. ISO9001/ ISO13485/ ISO14971/ cGMP / CE/ FDA/ MDSAP/ ISO14001).</li><li>Experience with complaint management (reporting), problem solving and CAPA investigations - Regulatory experience regarding same and/or qualification in related field.</li><li>Lead Auditor qualification or considerable internal audit experience necessary.</li><li>Excellent interpersonal, written and verbal communication skills, including ability to convey appropriate information with clarity and effectiveness. Pro-active attitude, excellent organisation skills, and ability to manage multiple projects while delivering results on time.</li><li>Experience of Cleanroom technology, SMT, PTH and IPC standards. Proficient with MS Word, Excel, Power Point. Familiar with use of online Quality Systems; QT9 a distinct advantage.</li><li>Conducts duties in line with Health and Safety policy.</li><li>Experience in regulatory requirements QSR, ISO/MDR.</li><li>A positive attitude is important while working in a fast-paced manufacturing environment and dealing with rapidly changing priorities maintaining communication and a sense of collaboration with colleagues, customers and vendors.</li><li>We are an equal opportunities employer but are only accepting candidates with a right to work in Ireland currently.</li></ul>

Senior Quality Engineer

Job Summary:The Quality Manager will be responsible for ensuring compliance with all relevant medical device regulations and quality standards, including ISO 13485 and FDA requirements. This role involves overseeing quality assurance processes, leading audits, and driving continuous improvement initiatives to enhance product quality and regulatory compliance. Key Responsibilities:<ul><li>Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485 and FDA regulations.</li><li>Lead internal and external audits, including regulatory inspections and supplier audits.</li><li>Oversee product quality and compliance throughout the manufacturing process.</li><li>Manage CAPA (Corrective and Preventive Actions) and non-conformance investigations.</li><li>Provide leadership and training to the quality team and production staff on quality best practices.</li><li>Collaborate with cross-functional teams to ensure quality objectives are met.</li><li>Drive continuous improvement initiatives to enhance product quality and reduce defects.</li><li>Ensure proper documentation and record-keeping in compliance with regulatory requirements.</li><li>Act as the primary point of contact for regulatory bodies and notified bodies.</li></ul>Required Qualifications & Skills:<ul><li>Bachelor’s degree in Engineering, Quality Management, or related field.</li><li>5+ years of experience in a quality management role within a medical device or regulated manufacturing environment.</li><li>Strong knowledge of ISO 13485, FDA regulations, and GMP requirements.</li><li>Experience in managing audits, CAPA processes, and risk management.</li><li>Excellent leadership, problem-solving, and decision-making skills.</li><li>Strong communication and interpersonal skills.</li></ul>Preferred Qualifications:<ul><li>Six Sigma or Lean Manufacturing certification.</li><li>Experience with regulatory submissions and compliance documentation.</li><li>Familiarity with validation and process improvement methodologies.</li></ul>Work Environment:<ul><li>Office and manufacturing floor-based work.</li><li>Occasional travel for audits and supplier visits may be required.</li></ul>

QA Manufacturing Compliance Specialist (Biologics) (Rotating day and evening shift) Job Dept: Quality Assurance Reports to: Quality Operations Manager Responsibilities <ul><li>Ensure that all products leaving the companies site meets the standards required for marketed and investigational drug products.</li><li>Ensure that products and aseptic process simulations manufacturedon site meets the requirements of the end users, regulatory authorities and of the company.</li><li>Providing quality and compliance oversight and assistance to the Operations function of the company to manufacture products in compliance with all site policies and procedures.</li><li>Provide quality oversight during the aseptic processing of products, including aseptic intervention observation.</li><li>Leading / Assisting in investigations arising out of product or manufacturing processes non-compliance.</li><li>Review/Audit of completed Batch Records.</li><li>Review of Manufacturing Logs as required.</li><li>Completion of quality review of operations documentation (SOPs, JSTMs, Risk Assessments)</li><li>Completion of Line Clearance activities.</li><li>Completion of Incoming Raw Material checks, including product status maintenance (as required).</li><li>Provide Stability Program Support, e.g. sample pulls, weekly checks, protocol generation (as required).</li><li>Finished product status maintenance, including labelling as required.</li><li>Administration of Quality Logs, e.g. QA Hold, Sample Request.</li><li>Lead operations floor daily walk around of manufacturing areas.</li><li>Drive continuous improvements and simplify site processes and procedure, specifically relating to the Operations function to ensure compliance is maintained at all times.</li><li>Other support as deemed necessary.</li></ul>Requirements <ul><li>Third level degree in a science, quality or engineering discipline.</li><li>Ideally previous experience in a quality role</li><li>A minimum of three years’ experience in a quality/operations role in a highly regulated GMP environment. Experience in biologics manufacturing is highly desirable.</li><li>Experience in aseptic processing gained within either a quality or operations role is highly desirable.</li><li>A strong knowledge of regulatory requirements is required.</li></ul>

Quality Assurance Compliance Specialist II

Quality Metrology Technician required Reporting to: Quality Manager   Job Description: The Quality Metrology Technician will be responsible for performing precision measurements and inspections to ensure that products meet established quality standards. This role involves using advanced metrology equipment and techniques to verify the accuracy and integrity of parts and components.   Key Responsibilities: <ul><li>Conduct precision measurements using a variety of metrology equipment, such as a PCMM (Portable Coordinate measuring machine – Faro Arm, Romer Arm), calipers, micrometers, and gauges.</li><li>Perform inspections on incoming materials, in-process components, and finished products to ensure they meet specified tolerances and quality standards.</li><li>Interpret engineering drawings and specifications to determine inspection criteria.</li><li>Record and analyse measurement data, identifying trends and deviations from specifications.</li><li>Collaborate with engineering and production teams to address quality issues and recommend corrective actions.</li><li>Maintain and calibrate metrology equipment to ensure accuracy and reliability.</li><li>Document inspection results and prepare detailed reports.</li><li>Support continuous improvement initiatives by providing feedback on inspection processes and quality control methods.</li><li>Assist in the development and implementation of quality control procedures and standards.</li></ul>  Qualifications: <ul><li>Associate’s degree or technical certification in metrology, quality control, engineering, or a related field.</li><li>Proven experience as a Quality Metrology Technician or in a similar role.</li><li>Proficiency in using metrology and inspection equipment, including PCMM, calipers, micrometers, and gauges.</li><li>Strong understanding of geometric dimensioning and tolerancing (GD&T) principles.</li><li>Ability to read and interpret engineering drawings and specifications.</li><li>Excellent attention to detail and precision in measurements.</li><li>Strong analytical and problem-solving skills.</li><li>Good communication skills, both written and verbal.</li><li>Ability to work independently and as part of a team.</li><li>Familiarity with quality management systems (e.g., ISO 9001, AS9100D) is a plus.</li><li>PCMM (Portable Coordinate measuring machines) such as a Faro Arm or a Romer Arm is an advantage.</li></ul>

Quality Metrology Technician

We are actively sekeing an experienced Manufacturing Engineer to join are clients site in Cork on a contract basis.  This role is a great opportunity for someone with strong Project Mangament experience looking to make a real impact to a global medical Device company. If you have strong experience in Validation Execution and Change Control Experience please reach out to discuss. Requirement: <ul><li>Level 8 Degree in Engineering, Science or related discipline or equivalent Technical experience.</li><li>Has 2 plus years’ experience in a manufacturing environment.</li><li>Business understanding of operations and there impacts essential.</li><li>High level of PC Skills required.</li><li>Flexibility essential.</li></ul> For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes.

Project Engineer Loughrea, Co. Galway This is an opportunity to be part of a dynamic team within the Engineering and Maintenance function. We are looking for individuals who will support and drive the vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers. Reporting to the Engineering Manager – Projects & Compliance, the Project Engineer will apply strong fundamental engineering expertise in support of design, commissioning and qualification of pharmaceutical equipment and building utilities within our site. Effective management of projects ensuring compliance with GMP and regulatory requirements. KEY RESPONSIBILITIES: Management of engineering projects, capital projects, compliance to GMP standards Preparation of user requirement specifications for various machinery/equipment and review of vendor designs/specifications Develop and execute FAT/SAT and commissioning qualification plans. Management of projects to agreed timelines and costs. Projects entail capital facility and equipment alterations and additions. Ensure Project compliance with environmental, health and safety standards. Ensure compliance to documented procedures and cGMP requirements are maintained to the highest possible standards. Achievement of KPI’s as outlined in Performance and Development Plan Lead project assignments and supervise outside contractors in compliance with company guidelines. COMPETENCIES: Organisational skills, personal efficiency, time management skills and the ability to prioritise competing demands, are key communication skills. Self-starter with demonstrated efficient work methods, analytical & problem-solving skills and ability to handle multiple tasks Ability to build relationships and collaborate with others is vital. Demonstrate and lead on the values, initiatives, and culture of an organisation. Professional expertise. QUALIFICATIONS: BS in Engineering or other technical discipline Minimum of 3 years engineering experience. Experience in a cGMP Manufacturing and or Biotechnology, pharmaceutical or medical device company is desirable. Ability to work on own and as part of a team. Demonstrated initiative and self-starter. Experience using any of the following AutoCAD software package is also desirable. PHYSICAL DEMANDS: Health & Safety requirements (e.g., Manual Handling Training) VDU Manual Handling WORK ENVIRONMENT: (e.g. Office, Production) Office, Production, Workshop, and Warehouse HOURS OF WORK: 08:30 – 17:00 (Monday – Thursday) 08:30 – 16:00 (Friday)

Job Summary:The Production Supervisor will oversee manufacturing operations in a medical device environment, ensuring efficient production, compliance with regulatory standards, and adherence to quality and safety protocols. The role involves leading a team, optimizing workflows, and driving continuous improvement initiatives. Key Responsibilities:<ul><li>Supervise daily production activities to meet output, quality, and efficiency targets.</li><li>Ensure compliance with medical device regulations (FDA, ISO 13485, GMP).</li><li>Train, mentor, and manage production staff to enhance team performance.</li><li>Monitor and enforce safety protocols to maintain a safe working environment.</li><li>Collaborate with engineering, quality, and supply chain teams to resolve production issues.</li><li>Implement lean manufacturing and continuous improvement initiatives.</li><li>Maintain accurate documentation and reporting for audits and compliance.</li><li>Troubleshoot and resolve equipment or process inefficiencies.</li><li>Support new product introductions and scale-up manufacturing processes.</li></ul>Required Qualifications & Skills:<ul><li>Bachelor’s degree in Engineering, Manufacturing, or related field, or equivalent experience.</li><li>3+ years of supervisory experience in a medical device or regulated manufacturing environment.</li><li>Strong knowledge of GMP, FDA regulations, and ISO 13485 requirements.</li><li>Excellent leadership and team management skills.</li><li>Experience with lean manufacturing and process optimization.</li><li>Strong problem-solving and decision-making abilities.</li><li>Effective communication and interpersonal skills.</li></ul>Preferred Qualifications:<ul><li>Six Sigma or Lean Manufacturing certification.</li><li>Experience with ERP/MES systems in a manufacturing setting.</li><li>Familiarity with validation and process improvement methodologies.</li></ul>Work Environment:<ul><li>Manufacturing floor and office-based work.</li><li>Requires standing for extended periods and working in a controlled environment.</li><li>Occasional evening or weekend shifts may be required.</li></ul>

Production Supervisor

EHS ENGINEER Responsibilities • Ensure that the highest standards of Environmental Health and Safety are maintained throughout the plant in an ever-changing business environment. • Foster a positive culture of continuous improvement while also ensuring that the site complies with all statutory Employment and EHS related legislation, Corporate Technical Standards and Policies. • Ensure compliance with all relevant EHS legislation and develop systems and procedures that optimizes the safety, health and environmental performance of the Site. • Ensure that effective contractor management systems and procedures are followed and maintain Contractor Safety Performance KPI’s. Requirements Essential Requirements • BSc in Occupational Safety & Health Level 8, or equivalent, or a degree in a related discipline is a necessary requirement for this position • 2-3 years relevant experience Desired Requirements • Internal Occupational Health and Safety Management System Auditor (ISO 45001 & ISO14001) Experience Required Technical/Business Knowledge -Job Skills/Experience Required • Provide direction and support to the site in meeting the requirements of the Global EHS Management and Technical Standards, ISO and other external regulations. • Maintain ISO 14001 and ISO 45001 Certification. • Liaise with Managers /Ensure employees are trained to a defined competency standard with all applicable EHS policies and procedures. • Perform Risk assessments throughout the plant and oversee and monitor training on risk assessments. • Ensure adequate training is in place to ensure that employees and contractors can perform their roles in compliance with all EHS standards. • Manage the EHS Assessment of all new chemicals and processes. • Implement ongoing evaluation of EHS awareness activities and develop continuous improvement on EHS programmes. • Provide EHS reports to Division and Corporate as requested. • Support, improve and continuously monitor the Site Emergency Response Plan to ensure it meets the requirements of changing processes. • Support the Emergency Response Team during an EHS emergency. • Support EHS activities during construction phases. • Assist in induction and training of new and/or existing employees. • Auditing to ensure compliance with safety standards and with the corporate management and technical standards. • Monitor and achieve environmental targets such as recycling, waste, emissions etc. • Maintain the Global incident reporting system. • Maintains and enforces the requirements of the sites environmental licence. Cognitive Skills • Sustained Attention, the position requires a high level of attention to detail and mental concentration, to ensure total compliance with safety policies, procedures and legislative requirements at all times. • Response Inhibition – avoid distractions. • Speed of Information Processing. • Cognitive Flexibility and Control, the position requires proven problem solving skills, and the ability to adapt to new manufacturing processes on a regular basis. • Multiple Simultaneous Attention. • Working Memory. • Category Formation. • The position requires proven technical skills, to ensure the person can cope with the technical demands of the position at all times. • The position requires the total commitment to quality and safety at all times. Ownership/Accountability • Every employee has a personal responsibility to commit to the Vision, to engage and align with the Strategic Imperatives, and to consistently execute in accordance with the  Operational Pillars and Ways of Work. Influence/Leadership • May be required to support Cross functional teams and cost improvement projects. Decision Making/Impact • Ability to make key strategic decisions in a timely manner in support of organisations, goals and targets complimenting a highly focused and effective organisation. Supervision Received/Provided • Supervision provided by Department Manager providing clear and concise goals and routine objective. EHS Responsibilities • Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities. • Continually be conscious of your own safety and that of others, always complying with safety notices and barriers. • Report any EHS incidents and/or Near Misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in EHS system. • Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on EHS system. • Attend all required EHS training and medical surveillance programs. • Wear PPE as required.

EHS Specialist II

Our client is currently seeking an experienced Quality Engineer to join our growing team based in our facility in Shannon, Co. Clare. This organisation has worldwide expertise but also a local presence within our specialized field. This will be a key role in the company and requires someone coming from a fast-paced multi-national company background. The successful candidate will have a minimum of 2-3 years experience in a similar role or environment and have a good working knowledge of ISO9001 and/or AS9100 Quality Management Systems. Excellent interpersonal and communication skills and ability to work under strict time constraints and work well in a pressurized environment. Must be computer literate and experienced in using MS office. Experience of NPI activity is desirable.  Key Responsibilities: <ul><li>Maintaining and updating the QMS documentation/records/systems</li><li>Driving process efficiency, resolving/providing feedback on issues</li><li>Conducting and reporting on internal audits as per annual schedule and closing-out of any non-conformances that arise</li><li>Analysing, identify and implement manufacturing and/or business process improvements which will improve capability performance</li><li>Assisting engineering teams on product/process verification for new and existing products. </li><li>Running CAPA systems and all related tasks. Lead quality problem investigations using proven quality tools.</li><li>Assist with operating and maintaining calibration systems.</li><li>Managing and co-ordination of various quality related projects and quality aspects of production programs</li><li>Provide quality support to operations, including leading and supporting root cause driven approaches to problem solving efforts for quality issues </li><li>Developing and implementing quality controls for new and existing product</li><li>Work individually and within teams on various Quality improvement and efficiency projects </li><li>Provide on-going communication through reports and information transfer as needed</li></ul> Requirements and Skills:   <ul><li>Proven to be self-directed, self-motivated and able to prioritize and resolve competing priorities.</li><li>Strong team member with the ability to identify and drive quality improvements.</li><li>Auditing experience in a manufacturing environment</li><li>Excellent interpersonal and organisational skills</li><li>Excellent verbal and written communication skills</li><li>Good investigative and problem-solving skills with excellent attention to detail</li><li>Decision making capability coupled with the ability to work independently and proactively</li><li>Knowledge and experience of materials, sheet metal and machining processes and or aerospace</li><li>Experience in APQP & PPAP’s would be advantageous</li></ul> For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes.

We currently have a a vacancy for an experienced Automation Engineer to join or Clients site in Clonmel Tipperary.  PURPOSE OF THE JOB: <ul><li>Ensure all plant automation systems are maintained and provide support as required.</li><li>Ensure all new equipment is validated as per Q.A. procedures.</li><li>Carry out continuous improvement on the production lines.</li></ul>  MAJOR RESPONSIBILITIES <ul><li>Responsible for consulting any SOP’s for any job task he/she may carry out and ensure they fully understand and adhere to the SOP.</li><li>Plan and schedule work in accordance with plant demand and available manpower.</li><li>Ensure all Abbott employees & contractors are fully familiar with all Safety Rules and regulations.</li><li>Ensure all efforts are made to reduce product cost by improving efficiencies.</li><li>Ensure no faults occur and if they do ensure adjustments are made and checks carried out until no fault exists.</li><li>Manage all plant automation systems ensuring compliance CFR 21/11 and other related policies and procedures.</li><li>Maintain and manage all aspects of Plant Batching System, manufacturing communication network and Predictive Control System.</li><li>Co-ordinate CAPA investigations impacting Engineering.</li><li>Manage maintenance of Medium Voltage Equipment.</li><li>Manage Manufacturing UPS Systems.</li><li>Measure and analyse trends in OSI PI, Scada etc.</li></ul>   EDUCATION & COMPETENCIES: <ul><li>You will have bachelor’s degree in engineering or equivalent discipline with 5 years relevant experience in Automation engineering. </li><li>Experience working with siemens PLCs is essential for the role. Experience working on ignition (scada) is an advantage</li></ul> For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes.

Automation Engineer

Job Summary:The Delta V Specialist will be responsible for the configuration, maintenance, and troubleshooting of Emerson Delta V Distributed Control Systems (DCS) in a manufacturing or industrial environment. The role involves working closely with process engineers, automation teams, and IT specialists to ensure system reliability, compliance, and optimal performance. Key Responsibilities:<ul><li>Design, develop, and implement Delta V DCS solutions for process automation.</li><li>Perform system configuration, software updates, and patch management.</li><li>Provide technical support and troubleshooting for Delta V hardware and software.</li><li>Develop and maintain control strategies, batch processes, and automation logic.</li><li>Collaborate with cross-functional teams to support commissioning, validation, and startup activities.</li><li>Ensure compliance with industry regulations (GMP, FDA, GAMP5) and internal quality standards.</li><li>Perform system backups, disaster recovery planning, and cybersecurity measures.</li><li>Train and support end-users on system functionality and best practices.</li><li>Document changes, system modifications, and operational procedures.</li></ul>Required Qualifications & Skills:<ul><li>Bachelor’s degree in Engineering (Electrical, Chemical, Automation, or related field) or equivalent experience.</li><li>3+ years of hands-on experience with Delta V DCS in a manufacturing or regulated environment.</li><li>Strong knowledge of process automation, control strategies, and batch processing.</li><li>Experience with system troubleshooting, configuration, and tuning.</li><li>Understanding of network architecture, PLC integration, and industrial protocols.</li><li>Familiarity with regulatory compliance in pharmaceutical or biotech industries (if applicable).</li><li>Excellent problem-solving skills and ability to work under minimal supervision.</li><li>Strong communication and collaboration skills.</li></ul>Preferred Qualifications:<ul><li>Delta V certification or Emerson training courses.</li><li>Experience in pharmaceutical, biotech, or chemical manufacturing environments.</li><li>Knowledge of scripting, SQL databases, or MES integration.</li><li>Experience with virtualized environments and cybersecurity best practices.</li></ul>Work Environment:<ul><li>Office and on-site work in a manufacturing or industrial setting.</li><li>Availability for on-call support and occasional travel may be required.</li></ul>

Delta V Specialist

Job Summary: We currently have a contract opportunity for a C&Q Engineer with a client located in Westport Co. Mayo. The C&Q Engineer will be responsible for the Generation, Execution and Approval of Qualification documents for Direct Impact Systems (Facility, Utility and Equipment) and the generation of Commissioning Test documents for Not direct Systems.   Requirements <ul><li>BS Degree in engineering, science or technical discipline required.</li><li>3 years of Commissioning and Qualification experience, ideally working in medical device or pharmaceutical organization.</li><li>Previous experience with clean utilities, hygienic piping, process instrumentation, controls and TOPs is</li><li>Familiarity with the risk-based approach to commissioning and qualification preferred. Familiarity with project management tools is advantageous.</li><li>Previous experience with Clean Utility tie-ins to existing systems is desirable (i.e Upgrading existing purified water skid to support a new tank).</li><li>Working knowledge of sanitary equipment, hygienic piping, process instrumentation and controls is desired Familiarity with the risk-based approach to commissioning and qualification preferred. Familiarity with project management tools is advantageous.</li><li>Adherence to cGMP and cGDP is mandatory. Strong technical writing skills are essential. The candidate must have a proven track record working within a fast paced GMP environment.</li><li>The candidate must be able to work independently with limited supervision – self-sufficiency is critical. They must demonstrate strong interpersonal & teamwork skills. Must be flexible to support unexpected project demands and maintain the overall program schedule.</li></ul> Main systems in scope of support: <ul><li>WFI Distillation, Storage and Distribution</li><li>Purified Water</li><li>POU Coolers</li><li>Partswasher  </li><li>Sterilization Autoclave</li><li>VHP</li><li>Freezers</li><li>Facility qualification</li></ul> For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes.

C&Q Engineer

Here at Sterling Engineering we are currently partnering with a reputable company in Shannon Co. Clare who is seeking an experienced Marketing Exective to join their Manufaturing site. This role would suit an engertic professional looking to lead the organisation marketing plan and make a real impact.  In this role you’ll get to: <ul><li>Create and manage new content and co-ordinate maintenance of five Company websites (WordPress).</li><li>Co-ordinate on campus events for both national and global customers.</li><li>Drive the company's Digital Marketing Strategy.</li><li>Contribute to our established CSR and Sustainability Strategy Initiatives.</li><li>Drive social media engagement through content management and creation.</li><li>Develop and issue PR communications through online, radio, print, and industry publications.</li><li>Manage Advertising campaigns aimed at Irish and International audiences.</li><li>Work closely with our HR Team in employer branding and recruitment activities.</li><li>Generate presentation and video content for Corporate and Training applications.</li><li>Provide marketing project support for international partners and distributors.</li><li>Manage and publish internal communications within the Company.</li></ul> We’re looking for people who have: <ul><li>A third level degree or equivalent in Business/Marketing/Communications or other relevant discipline.</li><li>3-5 Years Marketing Experience</li><li>Time management and task prioritisation skills.</li><li>Experience of working with WordPress/Adobe/Canva is desired.</li><li>Excellent knowledge of social media applications and their functions (Facebook, Twitter, Instagram, LinkedIN, YouTube).</li><li>Good project management and leadership skills</li><li>Experience in managing outsourced support functions such as web developers and graphicdesigners.</li><li>Experience in managing marketing collateral such as promotional materials and artwork.</li><li>Excellent communication and presentation skills.</li><li>A High-level of editorial and proof-writing skills</li><li>Creativity and Interpersonal skills</li><li>A keen eye for detail with a strong ability to multi-task</li></ul> For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes.

Marketing Executive

Toolmaker 40 hours per week Job description <ul><li>To manufacture, repair and service all tools – have the ability to dismantle, clean, repair and reassemble multi-impression tooling.</li><li>Attending Mould breakdowns to identify the root cause and solve the problem including flashing conditions, gating, venting and cooling problems.</li><li>Using machinery such as lathes, presses, milling machines and grinders.</li><li>Work effectively with all team members to assist in the continuous improvement.</li><li>Carry out Preventative Maintenance on tooling as per PM Schedule.</li><li>Any other duties as assigned by the maintenance and Tool Room Manager.</li><li>Maintain Moulds as defined in the General Maintenance Procedure.</li><li>Record all maintenance activity in appropriate files and compile reports.</li><li>Support the spare parts inventory system through assigning of all parts used and scheduled stock takes.</li><li>Ensure the safety of the working area.</li><li>Implement tool room housekeeping practices.</li><li>Performs other duties as assigned.</li><li>Ensure compliance to the Health and Safety, Quality, Environmental and Energy Management systems.</li><li>Following engineering drawings to measure and mark out the design for the tool.</li></ul>Profile of the candidate <ul><li>Ability to work as part of a team and on one's own initiative.</li><li>Qualified Tool Maker, equivalent with 3-5+ years post-qualification experience in an Injection Moulding Environment.</li><li>Experience required with hot runner system maintenance.</li><li>Referenceable track record in problem-solving.</li><li>Experience in factory environment an advantage.</li><li>Self-motivated, high energy, positive attitude with initiative for timely completion of goods.</li><li>Excellent practical skills.</li><li>Ability to show accuracy and attention to detail in work.</li><li>Ability to work to high specifications and quality requirements.</li><li>Good hand-eye coordination with an interest and an aptitude for engineering and practical work.</li></ul>

Toolmaker

Quality Engineer II Responsibilities: <ul><li>Ensure compliance with customer and regulatory quality systems (ISO 13485, FDA).</li><li>Develop and maintain effective inspection plans for incoming, in-process, and final products.</li><li>Investigate and resolve quality issues, including customer complaints, using CAPA systems.</li><li>Assess product/process changes for validation and quality impacts.</li><li>Manage product dispositions and update specifications/documentation as needed.</li><li>Write validation protocols, reports, and test documentation.</li><li>Lead quality audits (internal, supplier, customer, and regulatory).</li><li>Support continuous improvement using process data and Lean/Six Sigma methodologies.</li><li>Supervise and mentor a team of up to 4 staff.</li><li>Collaborate with customers and suppliers on quality matters and new product launches.</li><li>Adhere to safety, health, environmental, and energy management standards.</li><li>Perform additional duties as assigned.</li></ul> Qualifications: <ul><li>Degree/Diploma in Engineering, Science, or Quality, with 5+ years of experience in the medical device industry.</li><li>Strong regulatory knowledge (ISO 13485, FDA).</li><li>Six Sigma Green Belt (or higher); Lean Green Belt preferred.</li><li>Proven leadership, problem-solving, and communication skills.</li><li>Self-motivated with the ability to work independently.</li></ul>

Quality Engineer II

The Role:  The NPI department is responsible for managing the realisation of new or improved products working with various departments within the organization (such as Production, R&D, Quality, Purchasing, and Test Engineering). As part of the NPI department, you will be responsible for documenting, planning, monitoring and validating changes, as well as creating compliant product documentation in various European languages taking into account the relevant local standards and legislations. Responsibilities: <ul><li>Develop product documentation compliant with product standards but also local standards and legislations. This includes labels, packaging, manuals and datasheets.</li><li>Create the product parts list (BOM) on the ERP system for the relevant markets where products are going to be sold</li><li>Collaborate with graphic designer on packaging creation in relation to compliance and correctness of content.</li><li>Work with sales offices in relation to documentation validation</li><li>Assess change request received for validity and determine appropriate lead time for completion</li><li>Control implementation of all changes related to product documentation</li><li>Liaise with Purchasing with regards to expected delivery time for new or updated documentation</li><li>Document and communicate changes internally and externally with relevant stakeholders.</li><li>Support Production staff in the roll out and understanding of the changes</li><li>Assist Production with day-to-day queries.</li></ul> The Person: <ul><li>Bachelor of Business Studies (BBS) or Business & Law (BBL) degree</li><li>Proficient in English with strong communication skills</li><li>Excellent computer skills (MS office, teams, web)</li><li>Ability to work independently, think creatively, manage multiple tasks and deliver results in a collaborative environment.</li><li>A positive and energetic attitude</li><li>Detail oriented, highly organised, reliable, and resourceful with strong ethics</li><li>Fluency in German an advantage permanent basis. The position will be based in Shannnon. For further information about this position please apply.</li></ul> For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Documentation Specialist

We are currently recuiting for a motivated HR Generalist for a Shannon based client. This is an excellent opportunity for a HR Generalist wishing to grow their career in a dynamic manufacturing setting. The Job: <ul><li>Provide support in relation to high-volume recruitment, including scheduling interviews, tests, candidate replies, pre-employment medicals, etc.</li><li>Maintain training and development records, and provide guidance and information on training opportunities</li><li>Provide administrative support in relation to HR and Payroll.</li><li>Benefits guidance and administration</li><li>Deal with employee queries in relation to day-to-day HR issues</li><li>Maintain accurate employee, training and HR records</li></ul> The Person: <ul><li>Degree in Business / HR, or other relevant qualification</li><li>Experience working in a fast paced Human Resources environment</li><li>Experience in Human Resources in a manufacturing setting would be an advantage</li><li>High proficiency in Microsoft Office</li><li>Highly confidential</li><li>Strong organizational skills</li><li>Excellent interpersonal and communication skills</li></ul> For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes.

HR Generalist

Dept: Engineering & Technology Reports to: Senior Manager, Engineering Purpose: The Project Engineer is responsible for safely coordinating and leading projects associated with Process Improvements, Automation, Aseptic processing, New Processing equipment with some Facility / utilities modifications to incorporate same. The primary responsibility of the role is to ensure that Projects meet their agreed goals/targets on time and on budget. The E&T Engineer reports directly to the Senior Manager of Engineering who will give advice and support to ensure the equipment/facility/utilities design and goals/targets are achieved. Responsibilities: People • Safely coordinate and lead cross functional project teams for the delivery of processing equipment to the site based on planned timelines and scope. Processing equipment would include e.g., Packaging equipment, Assembly equipment, Inspection equipment, Autoclaves, RABS & Isolator Filling machines, LAF units, Compounding skids, Vessels etc. • Writing User Requirement Specifications. • Selecting Vendors and completing Vendor evaluation matrix. • Writing RCE's, placing orders, Project Management & Design review meetings. • Working to the ASME BPE 2019 Standard and relevant ISPE Guidelines etc. • Coordination of processing equipment installation and services hook up, working with Equipment Vendors and Engineering personnel. • Lead the Project Team participation in Factory Acceptance Testing program. • Coordination of all equipment documentation requirements. • Commissioning of equipment and Engineering support during qualification. • Work with the E&T Senior Manager & System Owner / Project Team. • Handover training, coordination of O&M manuals, Spare parts, & PM schedules. Product • Contribute to a team environment on specific technical problem-solving forums associated with Product manufacture & Aseptic fill. • Deliver on Process improvement / cost reduction projects. Meetings • Lead your regular weekly / bi-weekly Project review meetings with your Project team. • Attend the twice weekly E&T Tier 2 meeting with your manager. Key Requirements: Education and Experience/Knowledge • Third level qualification in an Engineering or equivalent discipline/experience • Experience of working in Biologics, Pharmaceuticals or Medical device industry. • Min of 2 to 5 years’ experience. • Project management experience with proven record • Assured self-starter with proven technical ability • Good communication and interpersonal skills required to operate in a multi-function project team set up. • Ability to work within a team using your own initiative to articulate and deliver specific functional requirements for all aspects of the project and work with members of various disciplines and functions across the project. • Good team leading skills and ability to work closely with other areas/departments within an organization. For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes.

Our client is seeking a skilled and motivated Electrician to join our team. The successful candidate will play a key role in maintaining and improving our manufacturing facilities, ensuring all electrical systems operate efficiently and safely. This is an exciting opportunity to work in a dynamic and high-tech environment. Key Responsibilities <ul><li>Perform routine maintenance, repairs, and troubleshooting of electrical systems, equipment, and machinery.</li><li>Install, test, and commission electrical systems and components in line with company and regulatory standards.</li><li>Conduct inspections and preventative maintenance to minimize downtime and ensure optimal equipment performance.</li><li>Collaborate with engineering and production teams to identify and implement electrical solutions for process improvements.</li><li>Ensure all electrical work complies with Irish electrical regulations and health & safety standards.</li><li>Maintain accurate records of maintenance and repair activities.</li><li>Assist in energy management and sustainability initiatives.</li></ul>  Qualifications & Experience Essential: <ul><li>Fully qualified electrician with a valid trade certification.</li><li>Minimum of 3 years of post-apprenticeship experience, preferably in a manufacturing or industrial setting.</li><li>Strong knowledge of electrical systems, schematics, and wiring diagrams.</li><li>Familiarity with Irish electrical standards and regulations.</li><li>Ability to troubleshoot and resolve complex electrical issues efficiently.</li><li>Excellent problem-solving skills and attention to detail.</li><li>Proficiency in using electrical testing equipment and tools.</li></ul>  Desirable: <ul><li>Knowledge of Lean Manufacturing principles.</li><li>Previous experience in energy efficiency or sustainability projects.</li></ul>  Skills & Competencies <ul><li>Strong communication and teamwork abilities.</li><li>Ability to work independently and manage time effectively.</li><li>Proactive approach to identifying and addressing potential issues.</li><li>Commitment to maintaining a safe working environment.</li></ul> For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Plant Electrician

Senior Automation Engineer Dundalk - Can also be located in Limerick. Salary: DOE - €55,000/85,000 Our Client produce high quality automation solutions that impacts on the execution of real-world machinery and processes. Our automation enables autonomous aqua drones to navigate the seas, robots to assemble complex products, pharmaceuticals to produce life-changing medicines. Our Client are a fast-growing company with great career opportunities, an ideal candidate would want to grow with them and have the vision of building the automation machines and solutions of the future. They are looking for a highly motivated, result-driven and confident Senior Automation Engineer.   As a Senior Automation Engineer, your role will be the development, commissioning and support of automation control systems across a wide spectrum of industries utilising cutting edge technologies. You will be responsible for system designs, standard library roadmap’s, specifications, programming, simulation, testing and overseeing commissioning. The candidate must possess the technical expertise to maintain, develop, troubleshoot and validate these systems in a compliant manner. Responsibilities: <ul><li>Manage the specification, development, installation and validation of automation projects within budget and corporate guidelines.</li><li>Software development of bespoke machines & manufacturing systems.</li><li>Interact with the customers on technical requirements.</li><li>Assess existing technologies and processes.</li><li>Design and deliver best in class automation solutions.</li><li>Work within a team and upskill junior engineers.</li><li>Document the project and manage change control.</li><li>Work independently and manage multiple tasks under tight deadlines.</li><li>Ability to take ownership of projects.</li></ul>  Qualifications: <ul><li>Third level qualification in Automation, Electrical, Mechanical, Electronic, Computer Science</li><li>5+ Years industry experience</li><li>Industry experience with preference for Rockwell Studio 5000, FT View, Ignition, Siemens TIA Portal/Step7, OSI PI Historian, VBA.</li><li>Knowledge of 21 CFR Part 11 and GAMP an advantage</li><li>Cisco Networking qualification and or VMware or equivalent qualification an advantage</li><li>Knowledge of Robotics and safety standards an advantage</li><li>Thorough knowledge of automation principles and procedures</li><li>Ambitious, confident and professional individual with strong communication and organisational skills</li></ul> Renumeration package to reflect experience and qualifications. By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes. For more information and a confidential chat please contact Gerard Cunniffe on +353 86 190 8885.

Snr Automation Engineer

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<h5>INVESTED IN YOUR SUCCESS.</h5><h5>What we do is more than a job.</h5>At Sterling, we work every day to create solutions to our clients&rsquo; business challenges while advancing our employees&rsquo; career objectives. We support your team in everything we do, from cutting-edge process development to hiring for your next success. Sterling drives expected outcomes while ensuring safety and compliance within your most complex projects.

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<h5>WHAT WE BUILD ON</h5><h5>At Sterling, we are driven by our values.</h5>For more than five decades, our commitment to quality has been the cornerstone of our success. We always act with integrity&mdash;taking responsibility for our work, caring for our people, and staying focused on safety and sustainability. Respect for people is at the heart of our business&mdash;clients and employees alike. We have an unrelenting focus on inclusion - we are a diverse, well-rounded team of thinkers and doers that embrace all perspectives. This culminates in a positive impact on the work we do.

WHAT WE BUILD ON<h2>At Sterling, we are driven by our values.</h2>For more than five decades, our commitment to quality has been the cornerstone of our success. We always act with integrity&mdash;taking responsibility for our work, caring for our people, and staying focused on safety and sustainability. Respect for people is at the heart of our business&mdash;clients and employees alike. We have an unrelenting focus on inclusion - we are a diverse, well-rounded team of thinkers and doers that embrace all perspectives. A diverse, well-rounded team of thinkers and doers helps Sterling embrace all perspectives. This culminates in a positive impact on the work we do.

<h5 style="text-align: center;">Since 1969, Sterling has been focused on cultivating relationships and&nbsp;is in the business of building trust.</h5>

INVESTED IN YOUR SUCCESS<h2>What we do is more than a job.</h2>At Sterling, we work every day to create solutions to our clients&rsquo; business challenges while advancing our employees&rsquo; career objectives. We support your team in everything we do, from cutting-edge process development to hiring for your next success. Sterling drives expected outcomes while ensuring safety and compliance within your most complex projects.

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<h2>PROUD TO BE WOMAN-OWNED.</h2><div class="flex-shrink-0 flex flex-col relative items-end"><div><div class="pt-0"><div class="gizmo-bot-avatar flex h-8 w-8 items-center justify-center overflow-hidden rounded-full"><div class="relative p-1 rounded-sm flex items-center justify-center bg-token-main-surface-primary text-token-text-primary h-8 w-8">&nbsp;</div></div></div></div></div><div class="group/conversation-turn relative flex w-full min-w-0 flex-col agent-turn"><div class="flex-col gap-1 md:gap-3"><div class="flex max-w-full flex-col flex-grow"><div class="min-h-8 text-message flex w-full flex-col items-end gap-2 whitespace-normal break-words [.text-message+&amp;]:mt-5" dir="auto" data-message-author-role="assistant" data-message-id="497c14f8-4331-4cd4-a0a0-847f5c2bf610" data-message-model-slug="gpt-4o"><div class="flex w-full flex-col gap-1 empty:hidden first:pt-[3px]"><div class="markdown prose w-full break-words dark:prose-invert light">We're excited to announce that Sterling Engineering Limited has officially met the qualifications to be named a Certified Women&rsquo;s Business Enterprise by WeConnect International!This certification reflects our commitment to diversity, leadership, and excellence, reinforcing our dedication to empowering women in business.&nbsp;We&rsquo;re proud to continue building strong partnerships and delivering top-quality engineering and staffing solutions with this recognition.<img src="https://cdn.sourceflow.co.uk/yi17tb2pmbvmyho8k83htie7aurb" alt="" width="400" height="179">&nbsp;</div></div></div></div></div></div>

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<h2>Engineering Services</h2><h5>Take your projects from planning to reality.</h5>Every project has a range of challenges that need to be met. If your organisation seeks expertise to identify and implement these solutions, you&rsquo;re looking for Sterling Engineering. With decades of experience and a wide range of knowledge, we analyse problems and design solutions.

<h2>Professional Services</h2>Take your projects from planning to reality.Every project has a range of challenges that need to be met. If your organization seeks expertise to identify and implement these solutions, you&rsquo;re looking for Sterling Engineering. With decades of experience and a wide range of knowledge, we analyze problems and design solutions.

<h2>Professional Services</h2><h6>Take your projects from planning to reality.</h6>Every project has a range of challenges that need to be met. If your organization seeks expertise to identify and implement these solutions, you&rsquo;re looking for Sterling Engineering. With decades of experience and a wide range of knowledge, we analyze problems and design solutions.

<h2>Engineering Services</h2><h6>Take your projects from planning to reality.</h6>Every project has a range of challenges that need to be met. If your organization seeks expertise to identify and implement these solutions, you&rsquo;re looking for Sterling Engineering. With decades of experience and a wide range of knowledge, we analyze problems and design solutions.

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<h3 style="text-align: center;">Outsourcing engineering project&nbsp;services enable companies to save time,&nbsp;money, and resources.</h3>

<h2 style="text-align: center;">PROJECT LIFE CYCLE</h2>End-to-end project delivery or a la carte services support all engineering and manufacturing stages.

<h3>Our process is engineered for your success.</h3>

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<h2>Outsourcing engineering project services enable companies to save time, money, and resources.</h2>

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Every project has a range of challenges that need to be met. If your organization seeks expertise to identify and implement these solutions, you&rsquo;re looking for Sterling Engineering. With decades of experience and a wide range of knowledge, we analyze problems and design solutions.

<h2>Professional Services</h2>&nbsp;<h6>Take your projects from planning to reality.</h6>Every project has a range of challenges that need to be met. If your organization seeks expertise to identify and implement these solutions, you&rsquo;re looking for Sterling Engineering. With decades of experience and a wide range of knowledge, we analyze problems and design solutions.

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<h4>THE STERLING ADVANTAGE.</h4><ul><li>Dedicated Delivery Teams:<ul><li>Project Manager</li><li>Coordinator</li><li>Researchers</li><li>Recruiters</li><li>Onsite Coordinator (as needed)</li></ul></li><li style="font-weight: bold;">Coordinate and manage secondary suppliers</li><li style="font-weight: bold;">Highly competitive pricing with centralised invoicing</li><li style="font-weight: bold;">Quality compliance and access to top talent</li><li style="font-weight: bold;">Tracking and analytics</li><li style="font-weight: bold;">Monthly/quarterly status reports</li><li style="font-weight: bold;">Flexible benefit programs</li><li style="font-weight: bold;">Technical expertise to deliver a statement of work</li></ul>

At Sterling, we pride ourselves on our exceptional recruitment process. We build strong partnerships with our clients, providing high-touch communication and in-depth prescreening to ensure the perfect match. Our advanced technology and extensive candidate database allow us to effortlessly locate technical candidates that may be difficult to find through other recruiting means. In addition, our dedicated industry-focused talent teams are profoundly knowledgeable and assess technical skills, cultural fit, and alignment with our client&rsquo;s values. We also provide comprehensive onboarding support for a seamless transition and long-term success. As a result, we deliver top-notch talent that aligns perfectly with our client&rsquo;s goals and culture.

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<h3 style="text-align: center;">Professional Service Offering</h3>As a Managed Service Provider (MSP), we specialise in managing and overseeing the staffing process for our clients. Our primary focus is to partner with you to help you efficiently acquire and manage your contingent workforce.&nbsp;

<h4>THE STERLING ADVANTAGE.</h4><ul><li>Dedicated Delivery Teams:<ul><li>Project Manager Coordinator Researchers Recruiters Onsite Coordinator (as needed)</li></ul></li><li>Coordinate and manage secondary suppliers</li><li>Highly competitive pricing with centralized invoicing</li><li>Quality compliance and access to top talent</li><li>Tracking and analytics</li><li>Monthly/quarterly status reports</li><li>Flexible benefit programs</li><li>Technical expertise to deliver a statement of work</li></ul>&nbsp;&nbsp;

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<h5>ENGINEERING SERVICES</h5>Sterling&rsquo;s experienced engineers can guide you from concept to prototype production or testing to manufacturing. With experience in multiple industries, we can deliver a creative approach to the project, accelerating time to market.Our experienced, multi-disciplined team of Project Managers, Engineers and Designers, led by licensed Professional Engineers (PE), provide Project Management, Engineering, Design, Commissioning, Qualification, and Validation (CQV) to Manufacturing, OEM, and R&amp;D customers.&nbsp;<h5>PROFESSIONAL SERVICES</h5>Our recruiters are experts in their related industries and talent skill sets. We leverage our industry relationships built since 1969, propriety database, and invested resources to connect you with the best engineering and technical talent.<ul><li>Recruiting structure driven by industry disciplines</li><li>We fully prescreen &amp; qualify candidates before submittal</li><li>90%+ of our business is from repeat clients</li></ul>

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<h2>Why Sterling?</h2>

Our recruiters are experts in their related industries and talent skill sets. We leverage our industry relationships built since 1969, propriety database, and invested resources to connect you with the best engineering and technical talent.&nbsp;<ul><li style="font-weight: bold;">Recruiting structure driven by industry disciplines</li><li style="font-weight: bold;">We fully prescreen &amp; qualify candidates before submittal</li><li style="font-weight: bold;">90%+ of our business is from repeat clients</li><li style="font-weight: bold;">2022 Manage HR Top Contingent Workforce Services Company</li><li>Best of Staffing Awards <ul><li>Client Satisfaction &ndash; 11 Consecutive Years  Talent Satisfaction &ndash; 10 Consecutive Years  Employee Satisfaction &ndash; 4 Consecutive Years</li></ul></li></ul>

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<h2>Service Summary</h2>Elevate your product development journey with our cutting-edge Product Engineering services. We specialize in guiding your product through every stage of development. Our focus on scalability and future-proofing anticipates growth and technological advancements, providing a solid foundation for sustained success. Choose our Product Engineering services for a strategic partnership that goes beyond development &ndash; it&rsquo;s about shaping the future of your product portfolio with innovation, efficiency, and quality at its core.<table style="border-collapse: collapse; width: 100.17%; height: 35px;" border="1"><colgroup><col style="width: 49.8305%;"><col style="width: 49.8305%;"></colgroup><tbody><tr style="height: 17.5px;"><td style="height: 17.5px;">Concepting</td><td style="height: 17.5px;">Detailing</td></tr><tr style="height: 17.5px;"><td style="height: 17.5px;">Product development</td><td style="height: 17.5px;">Reverse engineering</td></tr><tr><td>Simulation</td><td>Materials selection</td></tr><tr><td>Design for manufacturability</td><td>Prototyping</td></tr><tr><td>&nbsp;</td><td>&nbsp;</td></tr></tbody></table>

<h1>Process Engineering</h1>Let&rsquo;s engineer a solution together.&nbsp;

<h1>Product Engineering</h1>Let&rsquo;s engineer a solution together.&nbsp;

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<h3>Did you know Sterling also provides outsourced design and engineering solutions for the life science industry?</h3>Sterling Engineering has decades of experience working on complex, highly technical projects across various life science clients. We have streamlined our processes, best practices, and customization of manufacturing systems to meet your needs &ndash; saving you time and money.

<h1>Professional Services</h1>

Organisations may encounter various obstacles when searching for technical and engineering talent, such as:

<h3>Professional Services for Engineering providing</h3><h3>Temporary, Contract and Permanent Solutions.</h3>Don&rsquo;t see what you&rsquo;re looking for? Ask us about any skill or discipline.&nbsp;

At Sterling, we pride ourselves on our exceptional recruitment process. We build strong partnerships with our clients, providing high-touch communication and in-depth prescreening to ensure the perfect match. Our advanced technology and extensive candidate database allow us to effortlessly locate technical candidates that may be difficult to find through other recruiting means. In addition, our dedicated industry-focused talent teams are profoundly knowledgeable and assess technical skills, cultural fit, and alignment with our client&rsquo;s values. We also provide comprehensive onboarding support for a seamless transition and long-term success. As a result, we deliver top-notch talent that aligns perfectly with our client&rsquo;s goals and culture.

<h3>Industry Leading Staffing &amp; Recruiting</h3>

<h1>Project Management</h1>Let’s engineer a solution together.

<h1>Start-Up &amp; Documentation</h1>Let&rsquo;s engineer a solution together.&nbsp;

<h1>Strategy</h1>Let&rsquo;s engineer a solution together.&nbsp;

<h1>Transportation</h1>

<h2>JOIN OUR INTERNAL TEAM</h2>

<h1>Join Our Internal Team</h1>

<h2>Find Your Career With Sterling</h2>Sterling is fortunate to have a diverse and exceptional team of individuals with deep experience and expertise. We welcome professionals looking for new challenges, those starting their career journey, and those eager to seize new opportunities in their professional lives. With Sterling, you&rsquo;ll receive:<ul><li>Full benefits</li><li>Employment opportunities that give you flexibility and new challenges</li><li>Consistent opportunities that provide stability</li><li>Expert recruiters that advocate your unique skills</li></ul>

Equipment & Facility Qualification Engineer

Owen Clancy

Equipment & Facility Qualification Engineer

Automation Project Engineer

Visual Inspection Engineer

Continuous Improvement Manager

HR Manager

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