Documentation Specialist - Contract The Documentation Specialist is responsible for the coordination, execution, and maintenance of manufacturing documentation in a cGMP-regulated environment. This role ensures the timely progression of documents through all lifecycle stages and supports production, inventory, and quality compliance activities through accurate and efficient document control processes. Key Responsibilities: <ul><li>Coordinate internal and external review and approval of manufacturing documents.</li><li>Ensure documentation progresses in line with site policies, cGMP, and GDP requirements.</li><li>Act as the main point of contact for documentation processes within manufacturing.</li><li>Manage the flow of documents in and out of ABB documentation systems.</li><li>Support new product introduction (NPI), technology transfers (TT), and routine manufacturing through documentation readiness.</li><li>Revise, update, and format manufacturing documentation including MBRs, SOPs, forms, logbooks, and label templates.</li><li>Ensure alignment between batch records and executed processes.</li><li>Investigate documentation-related issues with quality/compliance impact and document outcomes.</li><li>Track operations/business metrics and report on schedule adherence and manufacturing KPIs.</li><li>Provide training and guidance on new or updated documentation.</li><li>Support inventory management and production documentation in SAP.</li><li>Interface with planning and procurement to support batch and purchase order management.</li><li>Maintain accurate records and ensure efficient execution of documentation across all manufacturing stages.</li></ul> Qualifications & Requirements: <ul><li>Bachelor’s Degree (Science or related field preferred) or equivalent experience.</li><li>Minimum 1 year of experience in document control/records management in a regulated industry.</li><li>Experience in a GMP manufacturing environment strongly preferred.</li><li>Proficient in Microsoft Office Suite (Word, Outlook, Excel, PowerPoint, Visio).</li><li>Expert in formatting, proofing, and editing GMP documentation for compliance.</li><li>Familiarity with electronic document management systems.</li><li>Demonstrated ability to manage documentation timelines in a fast-paced, deadline-driven environment.</li><li>Knowledge of SAP for inventory and production documentation is highly advantageous.</li></ul> For a confidential conversation about the role contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Documentation Specialist

Visual Inspection Engineer   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 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

Project Engineer - Automation Job Summary The Project Engineer is responsible for safely coordinating and leading projects associated with Automation, Aseptic processing, new processing equipment, packaging, new Facility builds or modifications/extensions. The primary responsibility of the role is to ensure that the project meets its agreed goals/targets on time and on budget. The engineer reports project progress to the Project Manager to ensure the equipment/facility design and goals/targets are achieved. Responsibilities <ul><li>Safely coordinate the delivery of processing equipment to the site based on planned timelines and scope. Processing equipment would include e.g. autoclaves, LAF units, moulds, extruders, packaging equipment, automated vision inspection systems, lyophilsers, isolators, containment booths, stopper processing eipment and equipment upgrades – both hardware and SCADA.</li><li>Coordination of equipment installation and services hook up, working with equipment vendors and engineering personnel.</li><li>Lead the Project Team or support the Project Manager in Factory Acceptance Testing program.</li><li>Coordination of all equipment documentation requirements.</li><li>Commissioning of equipment for validation activities.</li><li>Preparation of equipment training and maintenance protocols.</li><li>Report into the Project Manager on project progress and advice/support on key project outcomes</li><li>Contribute in a team environment on specific technical problem solving forums associated with product manufacture, aseptic fill and Packaging.</li><li>Deliver Process improvement projects.</li><li>Work with the relevant Business Unit team leaders to implement improvement opportunities</li><li>Lead regular Equipment/Facility Project review meetings.</li><li>Attend the weekly Tier Meetings.</li><li>Attend monthly Department Meetings</li></ul> Requirements <ul><li>Third level qualification in an Engineering or Science or equivalent discipline/experience (Automation)</li><li>Experience of working within either the medical device or bio/pharmaceutical industry would be an advantage but not necessary. 5 years+ experience.</li><li>Project Management experience is preferable but not necessary</li><li>Interpersonal skills required to operate in a multi-function project team set up.</li><li>Ability to work within a team and on 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.</li></ul> Essential Knowledge, Skills & Abilities: <ul><li>Experience of working on a team, including strong organizational and time management skills.</li><li>Exposure to process/equipment projects preferred.</li><li>Experience in a GxP regulated environment is preferred.</li><li>Experience with manufacturing systems is preferred.</li><li>Proficient in Windows Operating System, Microsoft Office and a good understand of PLC and Scada systems preferred.</li><li>Flexibility to respond to production issues outside normal business hours.</li><li>Ability to learn new and different technologies</li><li>Undertake any training or travel that the role may require.</li></ul> For a confidential conversation about the role contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Project Engineer

Director of Operations – Limerick The Operations Director will play a key role in scaling and optimizing production operations at a high-precision medical device manufacturing facility. Collaborating with senior leadership, this role ensures manufacturing capacity meets growing demand while maintaining top-tier quality and regulatory compliance. Key Responsibilities <ul><li>Manufacturing Oversight: Lead all production lines to meet targets in output, quality, and delivery while scaling operations efficiently.</li><li>Operational Excellence: Drive continuous improvement using Lean, Six Sigma, or equivalent methodologies.</li><li>Quality & Compliance: Partner with QA to align operations with ISO 13485 and regulatory standards.</li><li>Supply Chain: Manage raw materials sourcing, vendor relationships, and inventory control.</li><li>Strategic Planning: Execute capacity planning, capital investment strategies, and tech integration.</li><li>Team Leadership: Build and mentor high-performing, safety-focused production teams.</li></ul>Required Experience & Skills <ul><li>10+ years in manufacturing leadership within precision or regulated industries</li><li>Strong background in toolmaking, machining, or related trades</li><li>Demonstrated success with Lean, Six Sigma, or TPM implementation</li><li>Data-driven problem solver with rapid troubleshooting abilities</li><li>Familiarity with ISO 13485 and FDA standards</li></ul>Preferred Qualifications <ul><li>Degree in Engineering, Operations, Manufacturing, or related field</li><li>Lean Six Sigma certification (Green or Black Belt)</li><li>Experience with digital manufacturing, CAD/CAM, or Industry 4.0 tools</li></ul>Leadership & Culture Fit <ul><li>Hands-on leadership—comfortable engaging directly with floor teams</li><li>Results-driven and pragmatic</li><li>Strong cross-functional collaborator</li><li>Composed under pressure in dynamic, growth environments</li><li>Future-focused with a proactive mindset</li></ul>

Director of Operations

Program Manager Location: Mayo Role Overview: The eBR Program Manager will lead the implementation of electronic Batch Records (eBR) and Review by Exception (RBE) at the Mayo site. This role is responsible for managing the project end-to-end—covering requirements gathering, system design, validation, and change management—ensuring alignment with Quality and Digital Transformation strategies. Key Responsibilities:<ul><li>Develop and manage a detailed project plan covering timelines, resources, and milestones.</li><li>Lead cross-functional teams and external partners through all phases of implementation.</li><li>Ensure compliance with IT and Quality policies, including system validation.</li><li>Track and report project costs, savings, and overall ROI.</li><li>Provide regular updates to senior leadership and contribute to broader Digital Transformation initiatives.</li><li>Support process redesign and stakeholder engagement to drive adoption.</li><li>Promote EHS and compliance across all project activities.</li></ul>Qualifications & Skills:<ul><li>Bachelor’s degree in Engineering, Science, or Technology (preferred).</li><li>Project Management certification is a plus.</li><li>6+ years’ experience in manufacturing, supply chain, engineering, or related areas.</li><li>Strong project leadership and cross-functional collaboration skills.</li><li>Proven ability to influence stakeholders and manage complex programs.</li></ul>

Program Manager eBR

Senior Manufacturing Engineer – Limerick Temporary – 6 Month Contract - Strong Possibility of Extension Position: My client is seeking an experienced Senior Manufacturing Engineer to join their team in Limerick on an initial 6-month contract, with a strong likelihood of extension. This role will play a key part in supporting the completion of a full validation pack for a new automated packaging line, offering the opportunity to contribute significantly to a high-impact technical project. Responsibilities: <ul><li>Provide advanced technical and engineering support within the manufacturing cell.</li><li>Work closely with engineering leadership to deliver key business objectives.</li><li>Drive the development and implementation of world-class manufacturing practices in a production environment.</li><li>Lead technical support for specific product and process-related issues.</li><li>Monitor line performance and implement structured improvement activities to optimize overall equipment effectiveness (OEE).</li><li>Lead or support validation activities including URS, VP, DQ, EQ, MSA, and PQ.</li><li>Note: You will not be required to approve validations, but strong experience in drafting, executing, and leading these activities is essential.</li><li>Contribute significantly to validation documentation and execution for a new automated packaging line. Experience in packaging and/or automation is advantageous but not essential.</li><li>Conduct Gauge R&R studies and support validation for new products and processes.</li><li>Apply Six Sigma and Lean methodologies to structured problem-solving efforts.</li><li>Lead strategic projects (value stream and cross-functional), including scoping, approval, budgeting, execution, qualification, and handover.</li><li>Continuously monitor and report on key business metrics and proactively resolve performance issues.</li></ul> Requirements: <ul><li>Level 8 Degree in an Engineering discipline.</li><li>Minimum 2 years of experience in a manufacturing environment, with practical validation experience.</li></ul> Desired: <ul><li>Strong background in leading or supporting validation projects from URS through PQ.</li><li>Confident and effective decision-maker with the ability to influence stakeholders.</li><li>Excellent written and verbal communication skills.</li><li>Experience working in cross-functional teams and delivering technical projects.</li><li>Proven project management and process improvement capability.</li><li>Strong analytical and problem-solving skills with measurable results.</li><li>Ability to manage and prioritise multiple tasks in a fast-paced environment.</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 +353861908885

Manufacturing Engineer

Job Title: Service Engineer Location: Remote Status: Full-Time, Permanent Reports To: Technical Service Manager ________________________________________ Position Summary The Service Engineer is a vital member of the Service Team, responsible for providing high-quality technical support, service, and training to customers and distributors across Europe. This role requires a proactive, customer-focused professional with strong technical expertise and a willingness to travel regularly. ________________________________________ Key Responsibilities • Deliver on-site technical support across Europe to diagnose and resolve equipment issues. • Fulfil maintenance service contracts at customer locations in the Netherlands and Germany, using the Field Service App to perform required inspections and checks. • Travel a minimum of two days per week (excluding vacation weeks); some weeks may involve extended travel for customer visits or exhibitions. • Perform equipment installation and commissioning at customer sites. • Promote and sell maintenance service contracts during customer visits. • Troubleshoot and resolve issues via phone and email, ensuring all cases are logged accurately in Salesforce. • Conduct product demonstrations, highlighting equipment operation, features, and benefits—collaborating with the Sales Team as needed. • Provide technical training to distributors at the Galway facility; attend Galway-based training at least once per quarter for ongoing development. • Support setup and demonstrations at trade shows and exhibitions across Europe. ________________________________________ Qualifications and Requirements • Strong mechanical and electrical aptitude • Fluent in English (spoken and written) • Engineering or Electrical certificate/diploma preferred, or willingness to pursue relevant qualifications • Excellent communication and interpersonal skills • High attention to detail, accuracy, and conscientiousness • Strong organizational and time-management abilities • Proficient in Microsoft Excel, Word, PowerPoint, and other relevant business software (e.g., Salesforce, PDM, JDE, AX) • Flexible and adaptable to meet dynamic customer and business needs, including frequent travel ________________________________________ Core Competencies • Mechanical and electrical/electronic engineering skills • Ability to read and interpret technical drawings • Strong documentation and reporting capabilities • Self-starter with excellent prioritization and decision-making skills • Clear and professional communication with internal teams, distributors, and customers • Readiness and flexibility to travel frequently across Europe, sometimes on short notice 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

Service Engineer

Mechanical Utilities Engineer Job Dept: Site Engineering Services Reports to: Engineering Manager Responsibilities:  <ul><li>Manage the execution of engineering and facilities-related projects within the group.</li><li>Lead and implement equipment and process improvement initiatives across manufacturing and utilities.</li><li>Ensure the effective execution of day-to-day preventive and demand maintenance activities.</li><li>Establish performance goals, schedules, and timetables in collaboration with the Site Engineering Services Manager.</li><li>Support and assist in managing project plans across manufacturing, utility, and facility areas.</li><li>Coordinate maintenance activities to align with required schedules and compliance standards.</li><li>Prepare capital expenditure (CapEx) requests related to facility, plant, and equipment needs.</li><li>Develop and maintain monthly engineering performance metrics, including ownership of the Site Maintenance Excellence Program to drive operational efficiencies and cost savings.</li><li>Ensure audit readiness and compliance with regulatory, corporate, and divisional engineering standards.</li><li>Deliver timely management reports and maintain performance against relevant budgets.</li><li>Promote cross-training within the department to sustain preventive maintenance objectives.</li><li>Uphold and enforce safety standards and safe work practices.</li><li>Implement continuous improvement through equipment and process upgrades.</li><li>Support manufacturing equipment maintenance to meet legal and corporate standards.</li><li>Liaise with Global Engineering and relevant stakeholders as needed.</li><li>Oversee internal and external project execution for plant-related initiatives.</li><li>Ensure full implementation of all relevant Quality, Engineering, and Safety policies.</li><li>Supervise external contractors, including the development of performance metrics for third-party service providers.</li><li>Drive quality and performance in vendor relationships through negotiation and management.</li><li>Prepare and implement timely Corrective and Preventive Action (CAPA) plans.</li></ul> Requirements: Essential Requirements: <ul><li>Bachelor’s Degree: Engineering (Mechanical, Chemical, Electrical, Biomedical, Electronics) or Relevant Discipline</li></ul> Desired Requirements: <ul><li>Experience in Chilled Water, boilers, Potable Water distribution, Compressed Air Generation, LPHW, Building Management Systems, Environmental Management Systems, Electricity, Building Safety Systems and Building regulations is desirable.</li></ul>Technical/Business Knowledge -Job Skills/Experience Required: <ul><li>5+Years experience in Facility and Utility Engineering, preferably in a cGMP environment.</li><li>It may be necessary to re-design elements of manufacturing / utility / facility machinery to adapt to process conditions in order to improve efficiency with a demonstrated track record in managing budgets.</li><li>Experience in a Electricity, LPHW, Chilled Water and Potable Waer distribution, Compressed Air Generation, Building Management Systems, Environmental Management Systems, Building Safety Systems and Building regulations is desirable.</li></ul> For a confidential conversation about the role contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose

Mechanical Utilities Engineer

Senior Quality Engineer Location: Galway, Ireland About the Role We are looking for an experienced Senior Quality Engineer to join our team in Galway. This role is key to ensuring product and process quality for medical devices in compliance with global regulatory standards. Key Responsibilities <ul><li>Support new product introductions (NPI) and existing manufacturing operations.</li><li>Lead non-conformance, CAPA, and complaint investigations.</li><li>Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and MDR.</li><li>Collaborate with cross-functional teams on design controls, risk management, and validation.</li><li>Support internal and external audits and drive continuous improvement.</li><li>Manage supplier quality and mentor junior team members.</li></ul>Qualifications <ul><li>Degree in Engineering, Science, or related field.</li><li>5+ years’ experience in quality within a medical device or regulated industry.</li><li>Strong knowledge of regulatory standards, CAPA, and validation.</li><li>Experience with Lean/Six Sigma tools; CQE or Green Belt a plus.</li><li>Excellent problem-solving and communication skills.</li></ul>

Senior Quality Engineer

Position: Mechanical Program / Project Lead Location: Mayo Fixed Term Contract The Role: Our client, a global leader in the food and beverage industry, is seeking a highly skilled and dynamic Software and Mechanical Program/Project Lead to join their team on a fixed term contract. They are seeking an individual who will drive innovative solutions and manage complex projects that blend software and mechanical engineering within manufacturing operations. The candidate will be responsible for ensuring the seamless integration of mechanical systems and software applications, optimizing production processes, and maintaining high standards of quality and efficiency. They will be responsible for overseeing and coordinating the development and implementation of software and mechanical projects and will lead cross-functional teams to ensure projects are completed to a high standard, on time, and within budget. Responsibilities: <ul><li>Oversee the entire lifecycle of software and mechanical projects, from planning and design to testing and implementation.</li><li>Lead the design and development of mechanical systems and software applications, considering budget, timelines, and resource constraints.</li><li>Lead and mentor cross-functional teams, including engineers, designers, and technicians, to achieve project goals.</li><li>Ensure all projects meet high standards of quality and comply with national and local regulations and standards.</li><li>Troubleshoot issues and develop innovative solutions to resolve them promptly.</li><li>Conduct regular tests and experiments to improve components and processes, staying up to date with industry trends and technological advancements.</li><li>Utilize CAD and 3D CAD software to plan and execute mechanical design projects and integrate software applications for enhanced functionality.</li></ul> Qualifications/Requirements: <ul><li>Degree in Mechanical Engineering, Software Engineering, or a related field.</li><li>Prior experience working as a mechanical design engineer or software developer, or in a similar role within the manufacturing sector.</li><li>Proven ability to manage projects from start to finish, ensuring high standards and timely completion.</li><li>Strong analytical and problem-solving abilities, able to devise innovative solutions to complex problems.</li><li>Proficiency with tools such as CAD and 3D CAD software.</li><li>Strong verbal and written communication skills.</li></ul>

Project Manager / Controls

Senior Manufacturing Engineer Location: Galway Department: Operations Type: Full-Time Position Overview The Senior Manufacturing Engineer is responsible for supporting and optimizing the manufacture of medical device products. This includes leading process improvements, managing equipment and materials, providing production line support, and ensuring operational efficiency in compliance with quality and regulatory standards. Key Responsibilities Manufacturing & Process Engineering <ul><li>Lead manufacturing projects to develop, optimize, and validate production processes.</li><li>Collaborate with R&D and Quality teams to design and improve manufacturing procedures and workflows.</li><li>Execute process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), in line with the Quality Management System (QMS).</li></ul>Operations Support <ul><li>Provide routine support to production operations, helping the team meet daily, weekly, and monthly manufacturing targets.</li><li>Troubleshoot and resolve product, process, and equipment issues in collaboration with QA and operations teams.</li></ul>Equipment Management <ul><li>Select, install, maintain, and monitor manufacturing equipment to ensure optimal performance.</li><li>Address equipment problems and adjust process parameters as needed.</li></ul>Continuous Improvement <ul><li>Apply principles of Lean, Six Sigma, Statistical Process Control (SPC), and Key Performance Indicator (KPI) analysis to drive continuous improvement.</li><li>Identify and implement cost-effective solutions to reduce cost of goods sold (COGs) as part of commercial readiness and scale-up plans.</li></ul>Required Skills & Experience <ul><li>Bachelor’s degree (Level 8) in Engineering or a related field.</li><li>Minimum of 5 years' experience in the medical device industry.</li><li>Proven expertise in manufacturing process development and equipment management.</li><li>Solid understanding of quality management systems (QMS), process controls, and regulatory compliance.</li><li>Strong problem-solving and analytical skills.</li><li>Excellent communication skills with the ability to liaise effectively with internal and external stakeholders.</li><li>Self-motivated, with a demonstrated ability to work both independently and within cross-functional teams.</li><li>Strong organizational, presentation, and project management abilities.</li></ul>Preferred Attributes <ul><li>Experience working in a start-up or scale-up medical device environment.</li><li>Familiarity with urology or similar therapeutic areas is a plus.</li></ul>

Senior Manufacturing Engineer

MES Engineer (Mid-level) - Westport   Purpose Maintain the MES (POMSnet) environment; to author & maintain recipes & worksheets for our clients site. Troubleshoot and provide solutions for MES & SAP problems in recipe execution and recipe authoring.   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 <ul><li>Third Level qualification in suitable manufacturing, engineering or business course and/or suitable experience.</li><li>A minimum of 2 years authoring experience preferably using POMSnet.</li><li>Be familiar 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 an advantage.</li><li>Proven attention to detail and mental concentration, to ensure total compliance with procedures at all times.</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

MES Engineer

Quality Assurance Specialist/Qualified Person Dept: Quality Assurance Reports to: Quality Operations Lead   Responsibilities: <ul><li>Comply with EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 16: Certification by a Qualified Person and Batch Release; Article 47 of Directive 2001/83/EC.</li><li>Qualified Person is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the Product Specification File (PSF)/Marketing Authorisation (MA) and with Good Manufacturing Practice (GMP) for products manufactured at our clients Biologics site .</li><li>To ensure that products manufactured at our clients biologics site are manufactured in accordance with the relevant GMPs.</li><li>The Quality Assurance Specialist / Qualified Person (QP) is responsible for the disposition of bulk product manufactured at site as acceptable for release or reject based on the information available relating to the manufacture and testing of the product.</li><li>To disposition bulk product as acceptable for release, or reject, to ensure patient safety based on the information available relating to the manufacture and testing of the batch.</li></ul>  Requirements: <ul><li>Third level qualification in a science discipline with 5 years' experience in the pharmaceutical industry.</li><li>MSc in Industrial Pharmaceutical Science or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC</li><li>5 years industrial experience gained in an FDA and EMEA approved pharmaceutical environment.</li><li>2 Years’ experience gained within an aseptic processing environment, ideally gained within a quality function.</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

QA Complaince Specialist / Qualified Person

Quality Assurance Engineer required for position in a steel fabrication and aerospace environment. Degree in Engineering/equivalent technical qualification and/or sufficient industry experience required. 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. Experience of internal auditing is required as is excellent interpersonal and communication skills; have the 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.   Job Duties and Responsibilitie <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</li><li>Running CAPA systems and all related Lead quality problem investigations using proven quality tools.</li><li>Assist with operating and maintaining calibration</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 Skill <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>Excellent interpersonal and organisational</li><li>Excellent verbal and written communication skills</li><li>Good investigative and problem-solving skills with excellent attention to</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 would be advantageous.</li><li>Experience in PPAP’s would be 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 purpose

Quality Assurance Engineer

Reporting to: Head of Embedded Software We are currently recruiting for an Embedded Software Engineer for our leading Manufacturing Client located in Shannon, Co. Clare As a Embedded Software Engineer you will contribute to: <ul><li>Design & Development of new alarm & IoT sensor products</li><li>Design & Development of RF modules to connect these devices</li><li>Collaborating with Electronic Hardware, Mechanical, RF and other engineering teams</li><li>Bringing the new products & features through in-house validation and external approvals (e.g. RED testing)</li><li>Collaborating with the NPI teams to transition the new products & features into high-volume manufacturing</li></ul> Key Skillsets required: <ul><li>Modular C on micros e.g Microchip PIC, STM32.</li><li>Compilers e.g. IAR, XC8</li><li>RF protocol development (proprietary, BLE, LORA, Sigfox or other)</li><li>SCM e.g. Git</li><li>Obsessive about code quality</li><li>Good Problem-solving skills</li><li>Self-Motivated</li><li>Advantageous</li><li>Automated QA tools (e.g. LDRA)</li><li>Low power design, battery powered products</li><li>Familiar with CI/CD pipeline tools e.g. Jenkins, Azure DevOps, GitHub Runners</li></ul> Qualifications: <ul><li>BSc in Electronic Engineering, computer science or a related field, or significant equivalent experience.</li><li>3 years minimum experience developing embedded solutions</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

Embedded Software Engineer

Job Summary The Project Engineer is responsible for the safe coordination and execution of projects related to: <ul><li>New Product Introductions (NPIs)</li><li>Process improvements and automation</li><li>Aseptic processing enhancements</li><li>Installation of new processing equipment, and associated facility/utilities modifications</li></ul> The primary focus is to ensure all projects are completed on time, within scope, and within budget. This role reports to the Senior Manager of Aseptic Engineering, who will provide technical guidance and support throughout each project. Key Responsibilities <ul><li>Safely lead cross-functional teams to deliver processing equipment (e.g., Autoclaves, RABS/Isolators, LAF units, Compounding Skids, Containment Booths, Stopper Processing Equipment).</li><li>Author User Requirement Specifications (URS).</li><li>Lead vendor selection and evaluation process.</li><li>Write and submit Request for Capital Expenditure (RCE) documentation and participate in purchase processes.</li><li>Conduct project design reviews and manage project milestones.</li><li>Ensure compliance with ASME BPE 2019, ISPE Guidelines, and applicable industry standards.</li><li>Coordinate installation and utility hook-up of new equipment.</li><li>Lead Factory Acceptance Testing (FAT) programs with vendors and project teams.</li><li>Oversee equipment documentation collection and validation readiness.</li><li>Support commissioning, qualification, and handover activities including training, O&M manual collection, PM schedule development, and spare parts coordination.</li><li>Contribute to cross-functional technical forums focused on product manufacturing and aseptic fill challenges.</li><li>Drive process improvements and cost-reduction initiatives through engineering solutions.</li><li>Lead weekly/bi-weekly Project Review Meetings.</li><li>Participate in Tier 1 Engineering Meetings with your manager.</li><li>Ensure timely communication across departments and maintain alignment on project timelines and deliverables.</li></ul> Requirements Education & Experience: <ul><li>Bachelor’s Degree (or equivalent) in Engineering or a related discipline.</li><li>2–5 years of experience in Biologics, Pharmaceutical, or Medical Device industries.</li><li>Proven track record in project management and equipment delivery.</li></ul> Technical & Interpersonal Skills: <ul><li>Strong initiative and technical competency in project execution.</li><li>Working knowledge of aseptic processing and cleanroom equipment.</li><li>Familiarity with standards and regulations (e.g., ASME BPE, ISPE, GMP).</li><li>Excellent communication, organizational, and team leadership skills.</li><li>Ability to manage multiple priorities and cross-functional collaborations.</li><li>Self-directed, proactive problem solver with a collaborative mindset.</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

Purpose: Leadership for labeling project management, strategic and tactical label change planning and forecasting of label changes to ensure the Global Label Management organization meets its performance objectives. The position will lead packaging and artwork strategy and shared label strategy across the product lifecycle. Responsibility to lead cross functional teams and drive alignment for labeling projects including manufacturing, engineering, regulatory and supply chain, among others, to achieve the Perfect Label. Ensures assurance of supply and compliance to content and market requirements for new product launches, safety updates and other core labeling programs. Responsibilities: <ul><li>Global product leadership for strategic planning and forecasting of label change projects</li><li>Responsibility for accuracy and completeness of the Brief phase within the Artwork Management System and to ensure compliance with regulatory requirements</li><li>Project Management responsibility within the system for Production, Design and Asset workflows</li><li>Lead label change projects and associated deliverables for launches, site transfers, country/area specific changes and other labeling focused projects.</li><li>Lead the periodic formal review process for label change management and develop and report performance metrics within label change execution.</li><li>Ownership and leadership role within the Packaging and Artwork Strategy</li><li>Lead shared label strategy development and maintenance over the product life cycle</li><li>Change Plan ownership for labeling operations</li><li>Act as business process owner for specific labeling business processes and assume role of documentation subject matter expert</li><li>Lead role to represent GLM in early development labeling work including functioning as lead for labeling launch activity.</li></ul> Qualifications: <ul><li>Bachelor's Degree in Science, Engineering, Business or Supply Chain and minimum of 5 years' experience in Operations, Regulatory or Quality environment</li><li>Proficiency in English (both written and oral)</li><li>Experience working effectively across different cultures, multiple functional areas and in complex matrix environments</li><li>Excellent written and oral communication skills with all levels of management and personnel.</li><li>Demonstrated success in negotiating and problem solving skills</li><li>Strong interpersonal and organizational skills</li><li>Excellent leadership skills and a proven ability to drive cross functional collaboration.</li><li>Understanding of Regulatory, Quality and Supply Chain aspects of labeling and impact of non-compliance</li><li>Knowledge of applicable regulations and standards affecting Pharmaceutical, Device, Device/Combo Products, specifically regulations and standards affecting the Packaging and Labeling Quality System</li><li>Strong project management skills including stakeholder management,</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

Global Labelling Operations Manager

Project Manager – Sterling Engineering   The role will involve managing a number of client-based projects involving design, construction, commissioning, and handover. The role will primarily involve conceptual and detailed design support and co-ordination & project management, project budget and schedule management, project resource and contractor management, equipment procurement, interfacing with clients Maintenance, Automation, EHS, Quality, and Operations Depts or third party suppliers.  Responsibilities will include:   <ul><li>Manage all phases of projects from concept through to implementation and close-out. Manage the design, construction, commissioning and qualification, project schedule, and cost.</li><li>Maintain a strong safety culture and performance in the implementation of projects.</li><li>Ensure successful delivery of projects which meet business needs. Deliver cost-effective projects in line with our project management procedures and best practices.</li><li>Ensuring that projects and programs are proceeding according to scope, schedule, and quality standards</li><li>Developing and maintaining collaborative relationships with stakeholders.</li><li>Identify effective & innovative engineering design solutions which meet project client/end user requirements.</li><li>Plan and lead the delivery of projects which meet all regulatory requirements including safety, quality, and environmental requirements.</li><li>Ensure that equipment qualification activities are completed in line with local client procedures, cGMP, and best practices.</li><li>Generate and manage project schedules to plan and track project activities over the life-cycle of the project.</li><li>Manage project risk registers with appropriate monitoring and tracking of mitigation actions agreed.</li><li>Manage multi-discipline project stakeholder input as required for successful project delivery</li><li>Supporting the professional services aspect of the business to ensure the staffing and recruitment team's needs are met.</li><li>Executing validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).</li><li>Carrying out thorough Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) at the vendor's or Clients facilities.</li></ul> Experience Required: <ul><li>Excellent communication and organizational skills are required, with a proven ability to effectively engage with all levels of the organization.</li><li>Ideally, candidates should have experience in a Drug substance API manufacturing site, which may include familiarity with piping systems, drying systems, HVAC, utilities, reactors, centrifuges, vacuum systems, abatement and heat/cooling systems. Alternatively, experience in a drug product fill/finish facility, covering compounding, isolators, filling, lyophilizers, vision inspection systems, as well as packaging and labelling technology, is also valuable. A strong knowledge of medical device manufacturing would be a bonus and also considered.</li><li>Understanding of Clean and Black Utilities requirements.</li><li>Strong process engineering experience.</li><li>Experience in the design of automated equipment.</li><li>Recognised Qualification or Certification in Project Management is preferred</li><li>Familiarity with Front-End Studies (FES), detailed engineering, RFP’s, tender packages, and collaboration with design offices is important.</li><li>Proven experience in consulting, program/project management, business process management and improvement, gained from working within life sciences Pharma, Biologic’s or Medical Device industry.</li><li>Working knowledge of regulatory requirements (e.g. EU MDR, FDA, etc.) and their impact on Quality Management Systems and associated processes is a plus.</li><li>Understanding validation processes and executing validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).</li><li>Experience carrying out thorough Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) at the vendor's or Clients facilities to ensure that all equipment and systems meet the required specifications and performance standards before they are deployed to the operational site.</li><li>Confirmed ability to get results through leading others, organising, prioritising, and delegating workload is required</li></ul> Minimum Requirements: <ul><li>Candidates should hold at minimum a bachelor’s degree in Engineering (Mechanical, Chemical, Process) and at least 5 to 7 years of project management experience in the Pharmaceutical industry or Medical Device Industry.</li></ul>

Project Manager

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

ENGINEERING TECHNICIAN (ASSEMBLY) Dept: Engineering – Tooling, Moulding, Assembly Reports to: Automation Manager   Responsibilities: <ul><li>To work as a team member to support Moulding/Tooling, Assembly in line with all safety, regulatory and organizational requirements.</li><li>Advance performance of site through Key Performance Indicators and metrics.</li><li>Partner with Operations to ensure daily production is met.</li><li>Responsible to be Subject Matter Expert on routine maintenance of all areas of responsibility regarding equipment and process.</li><li>Interface and work with equipment vendors as required for detailed issue resolution.</li><li>Embrace and drive the site Maintenance Excellence Programme.</li><li>Fabrication of ad hoc mechanical and electrical parts to ensure efficient repairs, upgrades, maintenance.</li><li>Participating in project teams and completing assigned projects/tasks.</li><li>Providing technical support to operations to ensure production schedule is achieved including optimization of moulding and assembly process.</li><li>Providing technical support to operational and strategic projects when required.</li><li>Documentation of all activities in line with cGMP requirements.</li><li>Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems.</li><li>Execution of routine manufacturing documentation, commissioning and validation protocols on an ongoing basis.</li><li>Providing an efficient maintenance service to include Moulds/ Moulding M/C’s, Assembly and Test Equipment.</li><li>Perform equipment Calibration per procedural requirements.</li><li>Updating the Maintenance and Calibration systems and ensuring compliance.</li><li>Interpreting electrical and mechanical drawings for decision making and improvements.</li><li>Troubleshooting and resolution of day-to-day technical issues in<ul><li>Injection mould machine and tooling – Equipment, Process, Electrical/Mechanical tasks.</li><li>Assembly (automatic and semi-automatic)</li></ul></li><li>Equipment, Process, Electrical/Mechanical process, control systems.</li><li>Maintaining the overall cGMP of the production areas.</li><li>Execution of all work utilizing Maximo management system.</li></ul>  Requirements: <ul><li>Leaving Cert OR Sr. Level Trade Certificate OR Technical FETAC 6 from Level 3 institute or commitment to obtain same</li><li>Experience in following technical area<ul><li>Mold Tooling</li><li>Electrical</li><li>Automation</li></ul></li><li>Demonstrated computer skills such as</li><li>Operating Computer interfaced equipment.</li><li>Interfacing with ERP systems.</li><li>Minimum of 3 years in a high precision manufacturing industry post qualification</li><li>Proven problem-solving ability on complex equipment.</li><li>Minimum 2 year of experience in regulated manufacturing environment required.</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

Engineering Technician

Engineering Specialist Location: Ireland Industry: Manufacturing Company: <ul><li>Partnering with world-class manufacturers to deliver custom-engineered systems that drive operational excellence.</li><li>From modular assembly systems to ergonomic workstations and precision-built components, we help our clients meet the demands of regulated, high-volume production.</li><li>They lead with a people-first, Lean-focused mindset that’s all about continuous improvement</li></ul> Key Responsibilities: <ul><li>As an Engineering Specialist, you’ll serve as the critical link between the companies technical capabilities and our customers’ success. You’ll collaborate with leading companies in medical devices, life sciences, and advanced manufacturing—delivering engineered solutions that improve yield, efficiency, safety, and quality.</li><li>This is not a traditional sales role. It's hands-on, relationship-based, and strategically vital. You'll work closely with clients to shape high-impact solutions with measurable business outcomes.</li><li>A seasoned engineer who values both technical precision and commercial outcomes</li><li>Experienced in medical device or advanced manufacturing environments</li><li>A clear communicator and confident consultant who enjoys tackling problems</li><li>Motivated by autonomy, influence, and the potential for performance-based equity</li></ul>  Qualifications & Skills: <ul><li>Proven engineering experience in regulated industries like medtech or advanced manufacturing</li><li>A consultative, solution-oriented approach to problem-solving</li><li>Knowledge of modular systems, fabrication, or automation (a plus)</li><li>Familiarity with quality systems and regulatory environments</li><li>Strong communication skills with an ability to simplify complex ideas</li><li>A collaborative, impact-driven mindset</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

Engineering Specialist

Global New Product Development (NPD) Program Manager Location: Galway Reports to: Director, New Product Development Travel: Up to 10% annually Employment Type: Full-Time Position Overview The NPD Program Manager plays a critical role in driving the successful execution of new product development projects from concept through commercialization. Working cross-functionally with departments including Marketing, Product Innovation, Quality, Regulatory, Supply Chain, and Sales, this role ensures timely, efficient, and compliant delivery of product initiatives aligned with the company’s strategic objectives. The ideal candidate brings strong project management expertise, is highly organized, and excels in navigating complex cross-functional environments—particularly those involving global product launches. Key Responsibilities NPD Project Planning & Execution <ul><li>Manage multiple new product development projects from initiation to launch, ensuring alignment with scope, timelines, and deliverables.</li><li>Develop and maintain project charters, timelines, and status reports for active initiatives.</li><li>Facilitate the stage-gate process, ensuring milestone achievement and stakeholder approvals.</li><li>Proactively identify risks and implement mitigation strategies to prevent project delays.</li></ul>Cross-Functional Collaboration <ul><li>Serve as a central liaison across NPD, Regulatory, Quality, Supply Chain, and Marketing teams.</li><li>Partner with the Global NPD Quality Lead to ensure adherence to quality systems and documentation standards.</li><li>Coordinate with Operations and Marketing to support Go-to-Market (GTM) readiness and product launch execution.</li><li>Engage with external partners, including vendors and contract manufacturers, to ensure alignment with project goals.</li></ul>Process Optimization & Workflow Management <ul><li>Identify and implement improvements in NPD workflows, approvals, and document management.</li><li>Enhance project visibility and efficiency using tools such as Smartsheet, Tableau, or equivalent platforms.</li><li>Support the creation and refinement of Standard Operating Procedures (SOPs) and best practices for NPD.</li></ul>Budget & Resource Management <ul><li>Assist in monitoring project budgets to ensure cost-effective execution across development phases.</li><li>Track resource allocation and manage team capacity to prevent bottlenecks and maintain delivery momentum.</li></ul>Performance Tracking & Reporting <ul><li>Collaborate with NPD Operations to monitor and report key performance indicators (KPIs):<ul><li>Time-to-market</li><li>Budget adherence</li><li>Quality metrics</li></ul></li><li>Deliver weekly project updates and monthly executive-level summaries.</li><li>Conduct post-launch reviews to measure success and identify areas for continuous improvement.</li></ul>Training & Stakeholder Engagement <ul><li>Deliver training on NPD processes, tools, and governance to cross-functional teams.</li><li>Support global alignment by communicating project updates and ensuring regional stakeholder engagement.</li></ul>General Administration & Ad-Hoc Duties <ul><li>Assist with project documentation, dashboards, and reporting tools.</li><li>Support product demos, internal events, and executive presentations.</li><li>Collaborate across time zones with global teams, including occasional evening meetings when required.</li><li>Stay current on industry trends, regulatory changes, and best practices impacting NPD.</li><li>Perform additional duties as needed to support the success of the NPD team.</li></ul>Qualifications <ul><li>Bachelor’s degree in Business, Engineering, Life Sciences, or related field (Master’s preferred).</li><li>5+ years of experience in project or program management within product development.</li><li>Familiarity with medical device, healthcare, or regulated industries is a plus.</li><li>Proficiency with project management tools (e.g., Smartsheet, MS Project, Tableau, Confluence).</li><li>Strong interpersonal and communication skills with the ability to influence across functions.</li><li>Highly organized, detail-oriented, and capable of managing multiple priorities simultaneously.</li></ul>

Global NPD Program Manager

Vice President of Operations Location: Galway Reports to: Chief Executive Officer / Chief Operating Officer Industry: Medical Devices / Regulated Electronics Employment Type: Full-Time Position Summary We are seeking a seasoned and strategic Vice President of Operations to lead the scale-up of our manufacturing and supply chain functions. As the company transitions from pilot production to full commercial scale, this role will be critical in ensuring high-quality, regulatory-compliant manufacturing and operational readiness to support global growth. This role has direct responsibility for manufacturing operations, global supply chain, logistics, ERP systems, and post-market support, ensuring all activities align with regulatory requirements and business objectives. Key Responsibilities Manufacturing & Operations<ul><li>Lead the scale-up and daily management of manufacturing to meet commercial demand.</li><li>Ensure regulatory-compliant production in accordance with ISO 13485, FDA QSR, and EU MDR standards.</li><li>Drive lean manufacturing practices and continuous improvement initiatives.</li><li>Oversee warranty, returns, and post-market servicing logistics.</li></ul>Supply Chain & Logistics<ul><li>Develop and manage a scalable, resilient global supply chain.</li><li>Supervise direct and contract manufacturing partners, ensuring cost control, quality, and timely delivery.</li><li>Build and execute global logistics strategies to support product distribution and growth.</li></ul>Systems & Documentation<ul><li>Lead implementation and optimization of ERP systems for visibility, planning, and inventory control.</li><li>Ensure robust design documentation practices including BOMs, specifications, and change controls in collaboration with Engineering and Quality.</li></ul>Leadership<ul><li>Build and lead a high-performance operations team aligned with company goals.</li><li>Collaborate cross-functionally with R&D, Quality, Engineering, and Executive teams.</li><li>Contribute to strategic planning and long-term operational roadmap.</li></ul>Required Qualifications<ul><li>10+ years of experience in operations leadership within medical device or regulated electronics sectors.</li><li>Proven success scaling manufacturing operations, particularly in electronic devices.</li><li>Strong understanding of ERP systems in manufacturing/supply chain contexts.</li><li>Expertise in design controls, documentation processes, and BOM management.</li><li>Experience with contract manufacturing and global supply chains.</li><li>In-depth knowledge of ISO 13485, FDA QSR, and EU MDR.</li><li>Demonstrated results in operational efficiency, product quality, and team leadership.</li></ul>Preferred Attributes<ul><li>Experience with Class II diagnostic or monitoring devices.</li><li>Exposure to global product launches in US and EU markets.</li><li>Advanced degree (e.g., MBA, MEng) is a strong plus.</li></ul>

Vice President of Operations

Position Summary We are seeking a detail-oriented and proactive Senior Manufacturing QA Engineer to support product manufacturing quality across internal processes and external suppliers, including our contract manufacturer. You will be responsible for ensuring compliance with regulatory requirements, maintaining product quality, and supporting continuous improvement activities as we scale up production. This role is critical to sustaining a high standard of quality and regulatory compliance as we grow our commercial presence in the medical device market. Key Responsibilities Manufacturing Quality Oversight <ul><li>Provide QA oversight for electronic and system-level manufacturing at the contract manufacturer.</li><li>Monitor and analyze production quality metrics (e.g., FPY, defect trends, non-conformances).</li><li>Support inspections, sampling plans, and lot release activities.</li></ul>Non-Conformance & CAPA Management <ul><li>Lead root cause investigations and manage resolution of product and process non-conformances.</li><li>Develop and implement corrective and preventive actions in collaboration with CM and internal teams.</li><li>Track and report CAPA effectiveness and closure.</li></ul> Process Validation & Documentation <ul><li>Support or lead quality aspects of process validations (IQ/OQ/PQ).</li><li>Review and approve manufacturing documentation including SOPs, work instructions, and validation protocols.</li><li>Ensure proper change control for process and product changes (ECOs, deviations, etc.).</li></ul> Supplier Quality Management <ul><li>Participate in supplier audits and manage supplier quality performance.</li><li>Support the development of quality agreements with contract manufacturers and key suppliers.</li><li>Ensure incoming inspection criteria and procedures are in place and effective.</li></ul> Regulatory Compliance & Audit Readiness <ul><li>Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable standards.</li><li>Support internal and external audits, including notified body and regulatory inspections.</li><li>Maintain GMP documentation and audit trails related to manufacturing activities.</li></ul> Continuous Improvement <ul><li>Identify and implement process improvements to enhance product quality and reduce defects.</li><li>Champion quality culture across the manufacturing value chain.</li><li>Collaborate with R&D, Ops, and CM to drive design transfer improvements and production readiness.</li></ul> Qualifications <ul><li>Bachelor’s degree in Engineering, Quality, or a scientific discipline.</li><li>3–7 years of experience in quality engineering or manufacturing quality within a medical device or regulated industry.</li><li>Strong understanding of ISO 13485, FDA QSR, and related standards (e.g., ISO 14971, IEC 60601).</li><li>Experience with process validation, non-conformance handling, and CAPA systems.</li><li>Ability to interpret technical drawings, BOMs, and manufacturing documentation.</li><li>Excellent written and verbal communication skills; detail-focused and process-driven.</li></ul> Preferred Attributes <ul><li>Experience with contract manufacturing environments.</li><li>Certified Quality Engineer (CQE), Six Sigma, or auditor qualifications are a plus.</li><li>Hands-on experience with ERP, QMS, or eDMS tools (e.g., Greenlight Guru, MasterControl, etc.).</li><li>Comfortable in a fast-moving, small-team environment with high visibility and impact.</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 Manufacturing QA Engineer

Job Purpose:   Job description to define the job role expected of an Operational Technology Engineer relevant to the Manufacturing Site.   OT System SCADA Engineer role supports lifecycle management of Operational Technology Systems & applications across the Westport Manufacturing Site. The OT Systems Engineer will be expected to support all aspects of the Production OT systems and provide development and installation support for new hardware and software solutions.   Responsibilities: <ul><li>Support of Operating System platforms and OT software applications</li><li>Provision of technical support and direction to Manufacturing Operations, Validation Engineers, and IT support staff as part of Manufacturing project support and project execution including transfer to production.</li><li>Provision of support for root cause problem solving and the implementation of CAPA’s.</li><li>Assist with design and build of secure, robust, highly available fit‐for‐purpose and future proofed application environments.</li><li>Follow the site OT lifecycle management processes that meet or exceed regulatory expectation in respect of data integrity: data backup regimes and system recovery testing.</li><li>Creation of technical documents required to complete SDLC document set, and knowledge articles required by Tier 2 and Tier 3 support teams.</li><li>Support any safety or quality initiatives that require Operational Technology support.</li><li>Support cost savings initiatives onsite and within the Automation team</li><li>Participate in departmental and customer project status update meetings.</li><li>Support operational excellence activities to continuously improve our processes and eliminate waste.</li></ul>  Qualifications: <ul><li>Bachelor’s degree in information technology, Computer Engineering, or related discipline / equivalent experience.</li><li>3 to 5 years’ experience delivering IT services preferably within the Pharmaceutical and/or</li><li>Medical device industry.</li><li>System Admin Windows 10 and Windows Server 2012/2016/2019</li><li>Expertise in the following technologies: SCADA, Historian, Thin Client Manager, Active Directory and group policy permissions, XML/XSL, SQL DBA and the development of SQL Queries, Stored Procedures and Reporting.</li><li>Extensive experience delivering automation projects (PLC and SCADA).</li><li>Aseptic processing and or packaging equipment experience.</li><li>Experience with delivering complex projects, ideally related to manufacturing modernization / manufacturing system upgrades to support business critical process equipment.</li><li>Good analytical skills and a proven ability to problem solve and identify CAPAs for deviations relating to bugs, failures, and non‐conformances.</li><li>Strong verbal and written 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 purpose.

Operational Technology Systems Engineer

PROJECT COORDINATOR   Responsibilities: <ul><li>Manages the development and implementation process of company's products and services involving cross-functional teams focused on the delivery of new Medical Device products.</li><li>Estimates project levels of effort and resource requirements by using standard estimating techniques and tools, and by working with appropriate staff to understand scope of effort. Prepares project plans, schedules and budgets by using project management tools such as Microsoft Project and by working with appropriate staff</li><li>to understand tasks necessary to complete project.</li><li>Directs project execution by assigning tasks, tracking project schedules, identifying risks, and developing and executing contingency plans.</li><li>Assures project quality by using standard development methodologies and by working with SQA to develop and execute project quality plans.</li><li>Communicates project status by preparing standard status reports, and by leading and participating in departmental and customer project status update meetings.</li><li>Resolves project issues by working with team members, project customers (internal and external), and others as appropriate.</li><li>Consults with internal project groups by sharing project management knowledge and assisting other project team stakeholders in project management processes and techniques.</li><li>Responsible to raise Change Plan: drive impact assessment, present CP to CFT meetings and drive approval up to Change review board</li><li>Prepares, edits, files, assembles documentation such as reports or technical documents, records, or correspondence.</li><li>Maintains numerical, alphabetical, chronological and/or subject filing system.</li><li>Responsible for file maintenance and record keeping; locates and removes file material upon request.</li></ul>  Requirements: <ul><li>Bachelor's degree plus 5 to 7 years of related work experience with a good understanding of specified functional area, or Master's degree with 3-5 years of related work experience, or an equivalent combination of education and work experience.</li><li>Working technical knowledge and application of concepts, practices and procedures. General understanding of business unit/group function.</li><li>Will perform this job in a quality system environment.</li><li>Failure to adequately perform tasks can result in noncompliance with governmental regulations.</li><li>Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.</li><li>Exercises judgment within defined procedures and practices to determine appropriate action.</li><li>Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environmet</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

Project Coordinator

Responsibilities <ul><li>Ensure that the highest standards of Environmental Health and Safety are maintained throughout the plant in an ever-changing business environment.</li><li>Foster a positive culture of continuous improvement while also ensuring that the site complies with all statutory Employment and EHS related legislation, AbbVie Corporate Technical Standards and AbbVie Policies.</li><li>Ensure compliance with all relevant EHS legislation and develop systems and procedures that optimizes the safety, health and environmental performance of the Site.</li><li>Ensure that effective contractor management systems and procedures are followed and maintain Contractor Safety Performance KPI’s.</li></ul>  Requirements Essential Requirements <ul><li>BSc in Occupational Safety & Health Level 8, or equivalent, or a degree in a related discipline is a necessary requirement for this position</li><li>2-3 years relevant experience</li></ul>  Desired Requirements <ul><li>Internal Occupational Health and Safety Management System Auditor (ISO 45001 & ISO14001)</li></ul>  Technical/Business Knowledge -Job Skills/Experience Required <ul><li>Provide direction and support to the site in meeting the requirements of the AbbVie Global EHS Management and Technical Standards, ISO and other external regulations.</li><li>Maintain ISO 14001 and ISO 45001 Certification.</li><li>Liaise with Managers /Ensure employees are trained to a defined competency standard with all applicable EHS policies and procedures.</li><li>Perform Risk assessments throughout the plant and oversee and monitor training on risk assessments.</li><li>Ensure adequate training is in place to ensure that employees and contractors can perform their roles in compliance with all EHS standards.</li><li>Manage the EHS Assessment of all new chemicals and processes.</li><li>Implement ongoing evaluation of EHS awareness activities and develop continuous improvement on EHS programmes.</li><li>Provide EHS reports to Division and Corporate as requested.</li><li>Support, improve and continuously monitor the Site Emergency Response Plan to ensure it meets the requirements of changing processes.</li><li>Support the Emergency Response Team during an EHS emergency.</li><li>Support EHS activities during construction phases.</li><li>Assist in induction and training of new and/or existing employees.</li><li>Auditing to ensure compliance with safety standards and with the corporate management and technical standards.</li><li>Monitor and achieve environmental targets such as recycling, waste, emissions etc.</li><li>Maintain the AbbVie Global incident reporting system.</li><li>Maintains and enforces the requirements of the sites environmental licence.</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

EHS Engineer

Test & Debug Technician Location: Shannon, Co. Clare Industry: Manufacturing A leading manufacturing company based in Shannon is seeking a Test & Debug Technician to join their growing team. This role is ideal for a motivated and detail-oriented individual with a background in electronics testing, repair, and inspection. Key Responsibilities:<ul><li>Work as part of the manufacturing and design team to support production and development activities.</li><li>Conduct PCBA and full system functionality testing of electronic/electrical assemblies and sub-assemblies.</li><li>Debug and repair PCBAs and electronic components used.</li><li>Perform in-process inspections to ensure product quality and compliance with specifications.</li><li>Conduct failure analysis for customer returns and production yield issues.</li><li>Carry out NRB (Non-Recoverable Board) debugging and repairs.</li><li>Perform soldering and related operations using hand tools and standard techniques.</li><li>Use electronic test equipment such as multimeters, oscilloscopes, and power supplies.</li><li>Interpret and work from technical drawings, schematics, and documentation.</li></ul>Qualifications & Skills:<ul><li>A Level 7 qualification (or equivalent) in Electronics, Electrical Engineering, or a related discipline.</li><li>Minimum of 2 years’ experience in a similar test/debug technician role preferred.</li><li>Strong understanding of electronic systems and testing methodologies.</li><li>Excellent problem-solving skills and attention to detail.</li><li>Strong communication and teamwork abilities.</li></ul>What They Offer:<ul><li>Competitive salary based on experience.</li><li>Opportunity to work in a dynamic and innovative environment.</li><li>Supportive team and ongoing development opportunities.</li></ul>If you're passionate about electronics and enjoy working in a hands-on, technical role, we’d love to hear from you. 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 & Debug Technician

The focus of this role will be to primarily assist in the development, implementation and validation of control systems for state-of-the-art production assembly equipment.   The Job: <ul><li>Design, specification and development of appropriate control systems for custom designed automated Test and Assembly equipment.</li><li>Development of control software for all new machines</li><li>Commissioning and validation of new and modified control systems</li><li>Develop and implement control system software upgrades and manage the role out to all equipment.</li><li>Provide technical support to the machine build team throughout the entire project cycle, including design, machine build, debug and commissioning phases.</li><li>Contribute to design reviews with all relevant stakeholders</li><li>Create & maintain all relevant documentation for new & upgraded equipment.</li><li>Responsible for ensuring that project timelines and targets are achieved</li></ul>  The Person: <ul><li>Working knowledge of PLC / HMI programming</li><li>Ability to read / work with electrical drawings</li><li>Knowledge of robotics, servo electric and pneumatic motion control systems</li><li>Have good knowledge and understanding of machine safety requirements</li><li>Imaginative and creative approach to technical problem solving</li><li>Ability to prioritise tasks and manage time effectively</li><li>Ability to work independently and also as part of a team as necessary</li><li>Strong attention to detail</li><li>Excellent communication skills</li></ul>  Requirements: <ul><li>Qualification to level 7 or 8 in Automation, Mechanical, Electrical, Industrial Engineering or equivalent.</li><li>Must have proven experience in a similar role.</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

Controls Engineer

Job Dept: Engineering Reports to: Automation Engineering Manager   Responsibilities: <ul><li>To manage the execution of projects within the engineering group, carry out and implement equipment and process improvement initiative and to ensure the performance of day to day preventative and demand maintenance activity to maintain manufacturing and utility equipment.</li><li>Establish with the engineering manager the department goals, schedules and timetables for activities.</li><li>Assist with the management and supporting of manufacturing equipment development.</li><li>Electro-Mechanical troubleshooting</li><li>Validation of new processes and development of technical documentationIdentification of areas of opportunity for new technology</li><li>Preparation of capital expenditure requests</li><li>Design of new equipment and stations</li><li>Sourcing of new equipment</li><li>Equipment vendor liaison</li><li>Equipment technical transfer from other locations</li><li>Management of capital projects from inception to completion</li><li>Present project status to management, written and verbal</li><li>Deliver technical training</li><li>Maintenance of manufacturing equipment.</li><li>Preparation of capital expenditure requests for plant.</li><li>Develops monthly engineering metrics.</li><li>Ensure successful external, Division and Corporate audits.</li><li>Ensure compliance with calibration requirements, PM on manufacturing equipment and with instrument/equipment calibration as per schedule</li><li>Identification and implementation of manufacturing equipment related CIP’s.</li><li>Issue management reports as requested and on time.</li><li>Management of relevant budgets within target.</li><li>Cross train within manufacturing engineering.</li><li>Ensure safety standards are met and safe working practices adhered to.</li><li>Implementation of equipment/process upgrade in an environment of continuous improvement.</li><li>Support the Engineering Team in ensuring that manufacturing equipment is maintained to meet the required legal, divisional and corporate standards.</li><li>Liaise with Division Engineering as required.</li><li>Ensure the effective management of appropriate internal and external plant projects.</li><li>Implementation of all relevant policie relating to Personnel, Quality, Engineering & Safety.</li><li>Supervise external contractors.</li><li>Negotiate cost / quality effective external contracts.</li><li>Prepare appropriate CAPA plans and implement timelines.</li><li>Developing new processes and completion of validations</li><li>Conducting acceptance trials on new moulds for sub-assembly equipment and introducing these into production</li><li>Present project status updates at various management levels</li><li>Participate in Risk Management activities as required.</li></ul>  Requirements: <ul><li>Bachelor’s Degree: Engineering or Related Discipline</li><li>2 years plus of Experience as a Manufacturing Engineer.</li><li>Total combined minimum years of experience required 2.</li><li>Required to undertake specific investigations, and equipment monitoring, with the view to improve manufacturing performance e.g. reducing equipment downtime and maximizing output and yield.</li><li>It may be necessary to re-design elements of manufacturing equipment to adapt to process conditions in order to improve efficiency</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 process Engineer

Job Dept: Engineering Reports to: Automation Engineering Manager   Responsibilities: <ul><li>To manage the execution of projects within the engineering group, carry out and implement equipment and process improvement initiative and to ensure the performance of day to day preventative and demand maintenance activity to maintain manufacturing and utility equipment.</li><li>Establish with the engineering manager the department goals, schedules and timetables for activities.</li><li>Assist with the management and supporting of manufacturing equipment development.</li><li>Electro-Mechanical troubleshooting</li><li>Validation of new processes and development of technical documentationIdentification of areas of opportunity for new technology</li><li>Preparation of capital expenditure requests</li><li>Design of new equipment and stations</li><li>Sourcing of new equipment</li><li>Equipment vendor liaison</li><li>Equipment technical transfer from other locations</li><li>Management of capital projects from inception to completion</li><li>Present project status to management, written and verbal</li><li>Deliver technical training</li><li>Maintenance of manufacturing equipment.</li><li>Preparation of capital expenditure requests for plant.</li><li>Develops monthly engineering metrics.</li><li>Ensure successful external, Division and Corporate audits.</li><li>Ensure compliance with calibration requirements, PM on manufacturing equipment and with instrument/equipment calibration as per schedule</li><li>Identification and implementation of manufacturing equipment related CIP’s.</li><li>Issue management reports as requested and on time.</li><li>Management of relevant budgets within target.</li><li>Cross train within manufacturing engineering.</li><li>Ensure safety standards are met and safe working practices adhered to.</li><li>Implementation of equipment/process upgrade in an environment of continuous improvement.</li><li>Support the Engineering Team in ensuring that manufacturing equipment is maintained to meet the required legal, divisional and corporate standards.</li><li>Liaise with Division Engineering as required.</li><li>Ensure the effective management of appropriate internal and external plant projects.</li><li>Implementation of all relevant policie relating to Personnel, Quality, Engineering & Safety.</li><li>Supervise external contractors.</li><li>Negotiate cost / quality effective external contracts.</li><li>Prepare appropriate CAPA plans and implement timelines.</li><li>Developing new processes and completion of validations</li><li>Conducting acceptance trials on new moulds for sub-assembly equipment and introducing these into production</li><li>Present project status updates at various management levels</li><li>Participate in Risk Management activities as required.</li></ul>  Requirements: <ul><li>Bachelor’s Degree: Engineering or Related Discipline</li><li>2 years plus of Experience as a Manufacturing Engineer.</li><li>Total combined minimum years of experience required 2.</li><li>Required to undertake specific investigations, and equipment monitoring, with the view to improve manufacturing performance e.g. reducing equipment downtime and maximizing output and yield.</li><li>It may be necessary to re-design elements of manufacturing equipment to adapt to process conditions in order to improve efficiency</li></ul>

Automation Process Engineer

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

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

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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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<h1>Case Studies</h1>

<h1>Clients</h1>

<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.

<h2>Engineering Services</h2>

<h1 style="text-align: center;">CONTACT US</h1>

Knowledge Hub

Our approach to project planning is characterised by:

<h5>Our process is engineered for your success.</h5>

<h3>Why Choose Sterling?</h3>

<h1>Engineering Services</h1>

<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>

<h2>Why Choose Sterling?</h2>

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

<h1>Life Science</h1>

<h1>Manufacturing</h1>

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

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<h1>Delivering Engineering Projects and Resources since 1969</h1>

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.

<h2>Delivering Engineering Projects and Resources since 1969</h2>

<h1>Industries We Serve</h1>

Connect with a recruiter

Find Your Career With Sterling

<h1>Industry</h1>

YOUR ENGINEERING SERVICES PARTNER

PROFESSIONAL SERVICES YOU CAN TRUST

Industries We Serve

One click could change everything. Submit your CV today.

Send us CV

Kita Gandhi

<h1>Dolores Connolly</h1>

<h1>Our Solutions</h1>

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

<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.

<h3>Empowering Success</h3><h3>Together: Our Collaborative</h3><h3>Journey</h3>

<h5>Empowering Success Together: Our Collaborative Journey</h5>

<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;

<h2>Empowering Success Together: Our Collaborative Journey</h2>

<h2 style="text-align: center;">Professional Service Offering</h2>

<h1>Partnering with us</h1>

<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>

<h3>Why Sterling?</h3>

KEY DIFFERENTIATORS

<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>

KEY DIFFERENTIATORS

<h1>Pillar page</h1>

<h1>Equipment Engineering</h1>

<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;

<h1>Life Sciences Staffing Solutions</h1>

<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>

About Sean
Sean Byrne is a Mechanical Engineering graduate from the University of Galway, bringing over 28 years of experience in the Pharma, Biopharma, and Medical Device sectors. Before joining Sterling, Sean held senior leadership positions within several Site Leadership Teams at Baxter Healthcare, Abbott Vascular, Allergan Pharmaceuticals, and most recently, AbbVie, where he served as the Site Engineering Director at the Westport facility.
At Sterling Engineering, Sean specialises in engineering operations management, provides expert consultation to global companies within the life sciences sector and the ability to take on/lead projects/deliverables for clients that may not have internal capacity. Sean's expertise and knowledge enable clients to make better-informed decisions and achieve superior outcomes.
Extensive Experience has been gained in the following:
<ul>
<li>Sterile Fill Finish Aseptic Processing</li>
<li>Operations &amp; Engineering interim engineering support</li>
<li>Maintenance and Reliability Engineering</li>
<li>New Product Development &amp; Process Development</li>
<li>Capital Planning, Site Master Strategic Planning &amp; Business Continuity Planning</li>
<li>Automation &amp; Design of Automated Equipment including Robotics &amp; Vision Systems applications</li>
<li>IFM - Facility Management, Cleanroom Design, Critical Utility Systems</li>
<li>PMO - Project Management including EPCMV, Front End Planning, Feasibility Study &amp; Detail Engineering</li>
<li>Energy &amp; Sustainability programs</li>
<li>Engineering Consultation &amp; Lean Manufacturing Excellence</li>
</ul>
&nbsp;
Education &amp; Qualifications:
<ul>
<li>B.E. Mechanical Engineering, University College Galway</li>
<li>Diploma in Project Management , PMI&nbsp;</li>
</ul>

Sean Byrne

About Karl
With 19 years in recruitment, Karl is a seasoned professional known for connecting unique talents with the right roles.&nbsp;
His experience spans various regions including Europe, San Francisco, Dublin, and London - where he has recruited for global companies, established talent strategies, and specialised in sectors from hospitality to investment banking and now IT and Engineering.&nbsp;
Key to his success is his ability to actively listen, an approach that helps him understand clients' and candidates' needs. Passionate about tech advancements, he has built a vast network in IT and Engineering, maintaining respected relationships that drive his continued success in placing top talent in dynamic, evolving fields.
Outside of work, Karl is known for being heavily involved with various charities raising much needed funds for the local area and wild camping in beautiful Connemara or other parts of the coast of Ireland.

Karl Lippett

Gerard Cunniffe

Owen Clancy

Niall Finnerty

Tommy McKeown

About Gerard
With Sterling&rsquo;s expansion into Ireland &amp; Europe, Gerard joined the Sterling Engineering team in 2023. Gerard is a recruitment professional with over a decade of international experience in the Engineering and Construction sectors. Currently serving as the Recruitment Team Lead at Sterling Engineering , Gerard has been instrumental in driving talent acquisition strategies that align with the company&rsquo;s mission to provide exceptional project support and staffing solutions across various industries, including Life Sciences, Automation &amp; Robotics, Manufacturing, Tech, Food &amp; Beverage, and Construction.
His previous experience includes significant positions at 3D Personnel Ltd, LJB Recruit and Aspect Personnel. Gerard specialised in recruiting for key roles in the construction industry across Ireland, UK, Europe and Melbourne.&nbsp;
Gerard's known for building strong relationships with clients and candidates alike and is passionate about connecting top talent with leading organisations.
Outside of work, Gerard can be found at his local GAA pitch, running the roads or in his garden.
Education:
<ul>
<li>Bachelor of Business (Honours) from Institute of Technology, Sligo</li>
</ul>

Gerard Cunniffe 

About Robert
Robert Noble joined Sterling in 2012 following a 30 year distinguished career in the Pharmaceutical Sector. His role is to expand Sterling&rsquo;s engineering services offering and deepen support services to existing clients already engaged in this sector.
Robert was the former Director of Technology and Design Engineering for Abbott Labs&rsquo; Global Pharmaceutical Operations. He has chaired the Packaging Equipment for Pharmaceuticals (PEP) Industry Group for ten years and served on the Packaging Machinery Manufacturers Institute&rsquo;s (PMMI) Packaging Management Council for seven years. He is a graduate of the University of Illinois and has an MBA from Lake Forest Graduate School of Management.
Project Highlights:
Manorhamilton, Sligo, Ireland
<ul>
<li>Directed a cross-functional team to assess and select the location for a Potent Drug Manufacturing Facility, resulting in the selection of the Manor Hamilton site in Sligo, Ireland.</li>
<li>Developed comprehensive front-end planning, including site layout, equipment selection, and construction strategies for a greenfield plant.</li>
<li>Designed and oversaw the installation of a state-of-the-art potent tablet coater.</li>
<li>Oversaw the planning for the expansion of the plant to accommodate new product implementations.</li>
</ul>
&nbsp;
Sligo Medical Device Plant &amp; Irish Third-Party Medical Device Component Sites
<ul type="disc">
<li>Directed the manufacturability design of a combination product auto-injector, optimizing production efficiency and quality.</li>
<li>Managed a team responsible for coordinating third-party component manufacturing and final product assembly and packaging.</li>
</ul>
&nbsp;
Cork, Ireland
<ul type="disc">
<li>Managed a multi-plant team to transfer several product lines from Puerto Rico to the Cork facility.</li>
<li>Oversaw equipment procurement and modifications, technology transfer, and the regulatory approval process.</li>
</ul>
&nbsp;
Queensborough, UK
<ul type="disc">
<li>Identified and resolved a critical liquid manufacturing issue, preventing worldwide supply interruption for a life-saving pharmaceutical product.</li>
</ul>
&nbsp;
Ludwigshafen, Germany
<ul type="disc">
<li>Led the Capital Plan and execution of serialization/track-and-trace systems to meet global regulatory requirements.</li>
<li>Managed the selection and purchase of process equipment for a pharmaceutical extrusion suite.</li>
</ul>
&nbsp;
Campoverde, Italy
<ul type="disc">
<li>Executed Capital Plans for serialization/track-and-trace systems aligned with worldwide standards.</li>
<li>Directed the introduction of a new product, requiring the design and construction of a new production process suite.</li>
<li>Implemented packaging line automation and efficiency enhancements.</li>
</ul>
&nbsp;
Breda, Netherlands
<ul type="disc">
<li>Managed the development and implementation of packaging equipment for a greenfield high-rise automated warehouse.</li>
</ul>
&nbsp;
Singapore
<ul type="disc">
<li class="MsoNormal" style="mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; line-height: normal; mso-list: l1 level1 lfo1; tab-stops: list 36.0pt;">
Oversaw the planning of a greenfield R&amp;D pharmaceutical facility, ensuring modern design and operational excellence.
</li>
</ul>
&nbsp;
Rio de Janeiro, Brazil
<ul type="disc">
<li class="MsoNormal" style="mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; line-height: normal; mso-list: l0 level1 lfo2; tab-stops: list 36.0pt;">Directed the expansion of manufacturing and packaging capabilities to support the launch of a new product.</li>
</ul>
&nbsp;
Buenos Aires, Argentina
<ul type="disc">
<li>
Implemented automation projects to enhance the operational efficiency of the manufacturing site.
</li>
</ul>
&nbsp;
Membership organisations include:
<ul>
<li>
International Society of Pharmaceutical Engineers
</li>
</ul>

Robert Noble

About Donal
Donal O'Callaghan is a seasoned engineering professional with over 40 years of diverse experience in manufacturing, operations, engineering design, procurement, and construction. Since April 2023, he has acted as a Technical and Business Consultant with Sterling Engineering Ltd., where he focuses on driving sales and marketing initiatives, providing recruitment assistance, and overseeing the conceptual design of Life Sciences projects.
Prior to his role at Sterling, Donal co-founded Callaghan Engineering in 1990, leading the firm to become one of Ireland's premier multi-discipline consulting engineering companies. Under his leadership, Callaghan Engineering served over 200 clients, with more than 85% of sales derived from repeat business.
Throughout his career, Donal has held key positions in project management, with significant assignments in the biopharma and medical devices sectors. His commitment to engineering excellence and sustainability has driven his ongoing success in the industry. He has also acted as a Senior Inspector with An Bord Pleanala, mainly in the area of air/water pollution appeals.
Project Highlights:
<ul>
<li>Merck, Co. Cork: Project Manager for a &euro;36 million Media Manufacturing Plant and a $75 million membrane manufacturing facility.</li>
<li>Pfizer, Little Island: Oversaw a &euro;4 million Centrifuge Project and a &euro;1.5 million Front End Study.</li>
<li>Abbott Diagnostics, Longford: Directed a &euro;13.5 million facility upgrade in diagnostics.</li>
<li>Data Centre Facility, Dublin: Managed a &euro;55 million investment for a confidential client.</li>
<li>Amgen, Co. Dublin: Led a &euro;25 million Containment Project.</li>
<li>EU Presidency: Led an engineering team for Ireland&rsquo;s last Presidency of the EU, providing facilities for the print and broadcast media</li>
</ul>
Education &amp; Qualifications:
<ul>
<li>B.E. in Chemical Engineering, University College Dublin</li>
<li>Diploma in Project Management, University of Dublin</li>
<li>Member of The Institute of Directors (M.Inst.D)</li>
<li>Member of the International Society of Pharmaceutical Engineering (M.ISPE)</li>
<li>Chartered Engineer (CEng)</li>
<li>Fellow of Engineers Ireland (F.I.E.I)</li>
<li>Fellow of the Institution of Chemical Engineers (FIChemE)&nbsp;</li>
</ul>

Donal O'Callaghan

About Kita
Kita joined Sterling in 2021 as our Director of Life Sciences Engineering.
Kita has more than 20 years of engineering and management experience, including 16 years in engineering roles with Abbott Laboratories and AbbVie, a global research-driven biopharmaceutical company. Kita works to expand Sterling&rsquo;s engineering services offering and to deepen support services to existing clients already engaged in the pharmaceutical and medical device sectors.
Kita is a PMP-certified chemical engineer, project manager, and entrepreneur with experience in both large corporate and small business environments.&nbsp;
Project Highlights:
<ul style="margin-top: 0in;" type="disc">
<li class="MsoListParagraph" style="margin-left: 0in; mso-list: l0 level1 lfo1;">Implemented Calibration Streamlining Program at pharmaceutical manufacturing sites in Germany, Ireland, and UK.</li>
<li class="MsoListParagraph" style="margin-left: 0in; mso-list: l0 level1 lfo1;">Developed business processes and provided training in conjunction with implementing a new corporate CMMS system at multiple European manufacturing sites.</li>
<li class="MsoListParagraph" style="margin-left: 0in; mso-list: l0 level1 lfo1;">Evaluated site infrastructure and generated site master plan, five-year long-range plan, and expansion conceptual design for Netherlands pharmaceutical warehouse.</li>
</ul>
Education &amp; Qualifications:
<ul>
<li>Bachelor of Science degree in Chemical Engineering from Washington University in St. Louis</li>
<li>Master of Science degree in Chemical Engineering from the University of California, Berkeley.</li>
</ul>

About Tim
Tim Silkaitis joined Sterling Engineering in 1992 as an Accounting Clerk. In 1997, he was promoted to an Accounting Manager and then in 2006 to Controller. As VP of Finance, he oversees all financial matters &mdash; including P &amp; L, 401(k), payroll services, and health insurance.
Tim is responsible for legal and contract administration and has IT department oversight.
Education:&nbsp;
<ul>
<li>Bachelors of Science Degree from Elmhurst College</li>
<li>MBA from DePaul University.</li>
</ul>

Tim Silkaitis

About Mark
Mr. Howard has extensive experience owning and operating two successful start-ups through sale. One acquirer was Waterlogic Plc, a publicly traded company on the AIM Exchange in London. Post acquisition he stayed on as Vice President of Sales and was part of the mergers and acquisitions team. 
Since joining Sterling Engineering in 2012 he has been a valuable contributor with progressive leadership roles primarily focused on our Life Science business vertical as well as in Sales and Operational leadership across the Technology, Health/Wellness, Facility, Manufacturing, and Engineering sectors.&nbsp; 
Mr. Howard was part of the tactical team sent to evaluate expanding Sterling Engineering&rsquo;s operations to Europe in 2019. As Senior Executive Vice President, Mr. Howard oversees operations for the Engineering Services Company and our European entity officed in Ireland.
Positions held: Sales Representative, Business Development Manager, Branch Sales Manager, Regional Manager, National Vice President of Sales, President/CEO.
Mark is proud to be a member of the&nbsp;<a href="https://diversityallianceforscience.com/">Diversity Alliance for Science</a>.

Mark Howard

About Dolores
Ms. Connolly is one of thirteen children born and raised to entrepreneurial parents in Co. Longford. She attended Loreto Convent in Mullingar, Co Westmeath and a certificate in childhood education from Association Montessori Internationale in London. In 1979 she was recruited to work for Alquin Montessori just outside of Chicago, Illinois.
Dolores appetite for business called when she left education and joined Danka Corporation, a global technology company. Over a 15-year career there she worked herself up the ranks to become Regional Vice President for Sales &amp; Services prior to joining Sterling Engineering and her husband, founder, Dan Casey.
She made an immediate impact in the business and worked her way up to the role of CEO at Sterling Engineering in 1997, a position she holds to this day. With 500+ employees, under Dolores&rsquo; tenure the business has grown by over 70% from when she started with annual revenues greater than &euro;50 million euros.
Dolores and Dan both being natives of Europe decided to open their EMEA Headquarters for Sterling Engineering in Ireland, with locations in Dublin and Galway. This new venture is driven by Sterling&rsquo;s global client demands to expand our world class service beyond North America. Ireland was a natural choice for Sterling&rsquo;s expansion plans.
Their partnership has not only highlighted success in business put is rich in philanthropic pursuits. For Dolores this started at an early age with the Simon Community (an Irish based organisation for the homeless) and the Prison Outreach Program in Ireland. Today, Dolores&rsquo; civic duty is primarily focused on STEM education initiatives and efforts prioritizing breaking the cycle of poverty, in particular for women and girls at a local and global level.&nbsp;
Dolores is proudly involved and an active member in several organisations:
<ul>
<li style="list-style-type: none;">
<ul type="disc">
<li class="MsoNormal" style="mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l0 level1 lfo1; tab-stops: list 36.0pt;"><a href="https://linkprotect.cudasvc.com/url?a=https%3a%2f%2fwww.concernusa.org%2f&amp;c=E,1,bZUYdPL8X90Kqx6uRBfEMP9kHpApjqWdq5NbHqEs-pLLJ7TV7sgvudphsSRhE0ojdkdaHyIDnWNeqUGzllNp_jT3CrC-4SUjUr4HDOxW&amp;typo=1">Concern Worldwide</a> Executive Board Member since 1996</li>
<li class="MsoNormal" style="mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l0 level1 lfo1; tab-stops: list 36.0pt;"><a href="https://linkprotect.cudasvc.com/url?a=https%3a%2f%2fiwfchicago.org%2f&amp;c=E,1,zVJrb3T0JX6gbfCKZE1ZytCmwErtOZnCLzzzuNL8tKYU62FIdhEITmKAsA_reyb2l75aBBD4nJpPTnmYh_63R_2ySjlTEnkNh_D9iKyg0ytC_vbOyhs,&amp;typo=1">International Women&rsquo;s Forum</a> Chicago, USA. Member since&nbsp;1998</li>
<li class="MsoNormal" style="mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l0 level1 lfo1; tab-stops: list 36.0pt;">Chicago - Galway Sister Cities Committee, Member since 2022</li>
<li class="MsoNormal" style="mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l0 level1 lfo1; tab-stops: list 36.0pt;">Chicago Council on Global Affairs,Presidents Circle, USA. Member since&nbsp;2001</li>
<li class="MsoNormal" style="mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-list: l0 level1 lfo1; tab-stops: list 36.0pt;"><a href="https://linkprotect.cudasvc.com/url?a=https%3a%2f%2fwww.chicago.gov%2fcity%2fen%2fdepts%2fdps%2fprovdrs%2fcert%2fsvcs%2fminority_and_womenownedbusinessenterprisecertificationmbewbe.html&amp;c=E,1,FveUp8msoaGG90SRvLRtpSGGot8pua9OLDIZNsmZR5UBitjfXFNw-cjKHZcVDGcCNdI1rBSIYka_4QzDrk0D4Y1fVrLpKo8vQDsO3mdvY1Pht9RZ1GCEpQ,,&amp;typo=1">WMBE Chicago&nbsp;</a> USA. WBE &nbsp;Member since&nbsp;2013</li>
<li class="MsoNormal" style="color: #ffffff;">Irish Books, Arts and Music (iBAM!) Award, Person of the Year, 2018</li>
<li class="MsoNormal" style="color: #ffffff;">Chicago Mother Jones Statue Committee 2021</li>
</ul>
</li>
</ul>

Director of Operations

Tommy McKeown

Documentation Specialist

Visual Inspection Engineer

Project Engineer

Director of Operations

Program Manager eBR

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