Senior R&D Engineer I Location: Mayo Department: Research & Development Role Overview The successful candidate will lead or support projects within the Core Business Initiatives (CBI) team, focusing on existing hydrophilic coated products and technologies. This role will also contribute to the development and integration of new materials, processes, and technologies into both new and existing products and manufacturing processes. The position requires a strong understanding of medical device design controls and the ability to work effectively within cross-functional teams, collaborating with colleagues at all organizational levels to deliver high-quality, customer-focused solutions. Key Responsibilities <ul><li>Provide technical support to New Product Development (NPD), Global Marketing, Engineering, and Manufacturing teams</li><li>Lead or support project teams in evaluating and demonstrating the feasibility of alternative materials, processes, or technologies for new and existing products</li><li>Prepare technical documentation in line with regulatory requirements, design controls, and internal development processes</li><li>Collaborate with cross-functional stakeholders to gather requirements and ensure proposed technical solutions meet business and customer needs</li><li>Develop experimental protocols and test plans, and manage product builds, transportation, storage, and testing activities</li><li>Conduct statistical analysis of test data and prepare detailed technical reports outlining results, conclusions, and recommendations</li><li>Represent the R&D function on cross-functional teams throughout the New Product Commercialization process</li></ul> Experience Requirements <ul><li>Minimum of 5 years’ experience in a technical role, ideally within Research & Development or Process Development</li><li>Experience with materials and coatings is required; knowledge of hydrophilic coatings and their application to various material substrates would be a strong advantage</li></ul> Educational Requirements <ul><li>Honours Bachelor’s or Master’s degree in one of the following disciplines:</li><li>Materials Science</li><li>Polymer Science or Engineering (Polymer or Biomedical)</li><li>Biochemical Engineering</li><li>Or a related engineering/scientific field</li></ul> Skills & Technical Knowledge <ul><li>Knowledge of hydrophilic coating technologies, materials science, and surface chemistry</li><li>Strong initiative with the ability to execute project responsibilities, overcome obstacles, and manage multiple priorities</li><li>Good understanding of medical device design controls and associated documentation</li><li>Proven experience working effectively as part of cross-functional technical teams</li><li>Strong problem-solving, decision-making, and root cause analysis skills</li><li>Ability to clearly communicate technical concepts and ideas to a wide range of stakeholders</li><li>Understanding of manufacturing processes, mechanisms, materials, tolerance analysis, and design for manufacturing</li></ul>

Senior R&D Engineer

Job Title:     Principal Scientist Location:    Mayo Status:     Permanent Position Summary: <ul><li>We are looking for a skilled Principal Scientist with deep expertise in polymers to join the team.</li><li>You will conduct high-level analysis of data, interprets results, communicates findings, supports the successful completion of global projects, supports the technical component of product development and drives innovation</li></ul>  Key Responsibilities: <ul><li>Lead the identification/sourcing, design, development, and optimisation of polymeric formulations</li><li>Provide technical leadership in the selection and development of polymer materials, technology, equipment and processes</li><li>Develop and execute experimental plans, including formulation testing, stability studies, and material performance evaluations.</li></ul> Qualifications and Requirements: <ul><li>Extensive experience in Polymer R&D and Manufacturing</li><li>PhD in Polymer Science, Materials Science, Chemical Engineering</li><li>Competent in the principles and practices of polymer formulations, adhesives and associated chemistry.</li><li>Materials science background with hands-on experience with sourcing, optimising and developing materials</li></ul>For a confidential conversation about the position 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

Principal Scientist

Job Title: CQV Lead Engineer Location: Athenry, Ireland Contract: 3 Month Fixed Term Job & Company Overview: Our client is a global leader in Medical Device Manufacturing working to transform how people manage their health. They are seeking a highly motivated and skilled CQV Lead Engineer to support the setup and validation of their new Greenfield manufacturing facility in Athenry. This is a 3-month contract role that will play a critical part in ensuring the successful construction, commissioning, and qualification of all facility, utility, and equipment systems. This position involves two key phases: <ol><li>Construction & Commissioning Oversight – Managing and coordinating Construction Complete, Turnover, and Mechanical Completion through Commissioning in collaboration with the General Contractor (GC).</li><li>Qualification Execution – Generating, executing, and approving Qualification documents for Direct Impact Systems (Facility, Utility, and Equipment).</li></ol> Key Responsibilities: <ul><li>Lead and coordinate Construction Completion, Turnover, and Mechanical Completion activities.</li><li>Oversee commissioning of all systems with the General Contractor (GC).</li><li>Develop, execute, and approve IQ, OQ, PQ qualification protocols for direct impact systems.</li><li>Work closely with cross-functional teams, including Engineering, Quality, and Operations, to ensure compliance with regulatory requirements.</li><li>Identify and resolve commissioning and qualification challenges to maintain project timelines.</li><li>Ensure adherence to GMP, FDA, ISO 13485, and other relevant regulations.</li><li>Maintain detailed documentation of all CQV activities.</li></ul> Requirements: <ul><li>Proven experience in CQV (Commissioning, Qualification, and Validation) within Medical Device or Pharmaceutical industries.</li><li>Strong track record in large-scale campus delivery of greenfield projects.</li><li>Expertise in Facility, Utility, and Equipment Qualification.</li><li>Knowledge of cGMP, FDA, ISO 13485, and industry best practices.</li><li>Strong project management and stakeholder coordination skills.</li><li>Ability to problem-solve and drive tasks to completion in a fast-paced environment.</li></ul> For a confidential conversation about the role please apply for the role or contact Gerard Cunniffe at gcunniffe@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose.

CQV Engineer

Job Title: Senior Robotics Engineer Location: Dundalk Salary: €75000 - depending on exp. Our client are seeking an experienced Senior Robotics Engineer to support the delivery of complex automation and robotics solutions within regulated manufacturing environments. This is a senior, hands-on role focused on the design, integration, commissioning, and optimisation of robotic systems, working closely with multi-disciplinary engineering teams to deliver high-quality, compliant automation solutions. The successful candidate will bring strong technical expertise in industrial robotics and controls, with the ability to lead technical delivery, mentor junior engineers, and contribute to project execution from concept through to handover. Key Responsibilities: <ul><li>Lead the design, development, and implementation of robotic automation solutions for manufacturing environments.</li><li>Program, configure, and commission industrial robots (e.g. Fanuc, ABB, KUKA, Yaskawa or similar).</li><li>Develop and support robot safety systems, including risk assessments and compliance with applicable standards.</li><li>Integrate robotics with PLC, HMI, vision systems, conveyors, and peripheral equipment.</li><li>Support FAT, SAT, and on-site commissioning, including technical documentation and troubleshooting.</li><li>Provide technical leadership across projects, supporting planning, estimation, and delivery activities.</li><li>Troubleshoot and resolve complex robotics and automation issues during build and operational phases.</li></ul> Skills & Experience: <ul><li>Degree in Automation, Mechatronics, Electrical, Mechanical Engineering, or a related discipline.</li><li>Significant experience as a Robotics Engineer in industrial or regulated manufacturing environments.</li><li>Hands-on experience programming and commissioning industrial robotic platforms.</li><li>Strong understanding of PLC-based control systems, industrial networks, and automation architectures.</li><li>Experience integrating robotics into automated production lines and complex machinery.</li><li>Knowledge of robot safety standards, risk assessments, and functional safety principles.</li><li>Exposure to pharma, biotech, medical device, or food & beverage environments is advantageous.</li><li>Familiarity with GMP, ISO, or other regulated manufacturing standards.</li><li>Experience with vision systems, motion control, and advanced automation technologies is beneficial.</li></ul> For a confidential conversation about the role please apply for the role or contact Gerard Cunniffe at gcunniffe@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose.

Senior Robotics Engineer

Digital Transformation Project Manager The Digital Transformation Project Manager is a pivotal leader driving the our clients site’s journey toward Factory 4.0. This role is responsible for coordinating a portfolio of digital transformation initiatives that enhance operational efficiency, optimise manufacturing processes and support the organisation’s commitment to innovation and operational excellence. The ideal candidate will bring a strong understanding of digital technologies, project and portfolio management, and regulated manufacturing environments, ideally within biopharmaceutical or advanced manufacturing settings. Key Responsibilities: <ul><li>Coordinate a portfolio of digital transformation projects, liaising with above-site teams and SMEs to represent the Westport site.</li><li>Collaborate with site leadership to develop and implement digital strategies aligned with operational and business objectives.</li><li>Work cross-functionally with IT, Operations, Regulatory Affairs and Quality to gather requirements and ensure alignment on project goals.</li><li>Drive value analysis and business case development for both new and existing digitalisation initiatives.</li><li>Own and/or support financial long-range planning and capital acquisition processes.</li><li>Communicate project status, risks, milestones and benefits to stakeholders at all levels.</li><li>Develop and implement effective change management strategies to ensure strong user engagement and adoption.</li><li>Represent the business/site in the deployment of digital tools and technologies, contributing to system architecture and configuration discussions as the operational voice.</li><li>Lead cross-functional project teams to deliver projects on time, within scope and with strong stakeholder engagement.</li><li>Define, track, and monitor KPIs to measure the success and sustainability of digital initiatives.</li><li>Ensure all initiatives comply with relevant regulatory requirements and internal quality standards.</li></ul> Qualifications: <ul><li>Bachelor’s degree in Business Administration, Information Technology, Engineering, or a related discipline.</li><li>Proven experience in digital transformation and project management, preferably in manufacturing or biopharmaceutical environments.</li><li>Experience with financial planning, budgeting, and business case development.</li><li>Exposure to Lean, Six Sigma, or other process improvement methodologies.</li><li>Strong interest in or knowledge of digitalisation and operational excellence (e.g. IoT, AI, robotics, Industry 4.0).</li><li>Excellent project and portfolio management skills, with the ability to manage multiple initiatives and cross-functional resources.</li><li>Strong communication, analytical, and problem-solving skills, with the ability to influence stakeholders at all levels.</li></ul> Preferred Qualifications: <ul><li>Master’s degree in a relevant field.</li><li>Certifications such as Lean Six Sigma Green/Black Belt, PMP, or Industry 4.0–related credentials.</li><li>Experience delivering Industry 4.0 or digital manufacturing projects in regulated environments.</li></ul> For a confidential conversation about the role please apply for the role or contact Gerard Cunniffe at gcunniffe@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose.

Digital Transformation Project Manager

Job Title:    Senior Packaging Engineer Location:    Mayo Status:      Permanent Position Summary: <ul><li>Seeking a Senior Packaging Engineer to join their Global Packaging team, where your work will directly impact patient care worldwide.</li><li>In this role, you’ll drive packaging solutions for their products, shaping packaging strategies from concept to commercialization.</li><li>You’ll collaborate across teams, influence critical decisions and ensure our products meet the highest standards of safety, performance, and innovation.</li></ul>  Key Responsibilities: <ul><li>Design, develop, and validate sterile and non-sterile packaging systems</li><li>Drive continuous improvement and cost-saving initiatives</li><li>Lead and own packaging projects for new product development and improvements to existing products</li><li>Ensure compliance with global regulations while representing Hollister at industry events</li></ul> Qualifications and Requirements: <ul><li>Deep knowledge of ISO 11607, ASTM, ISTA and EU MDR/FDA guidance</li><li>Strong technical writing, validation and statistical analysis skills</li><li>Packaging experience in medical devices or related industries</li></ul>  For a confidential conversation about the position 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 Packaging 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

Design Assurance Manager – Galway Role Summary The Design Assurance Manager is responsible for ensuring medical devices are designed and developed in compliance with applicable regulatory requirements and quality standards. This role provides leadership across design controls, risk management, and verification and validation activities throughout the product lifecycle, while partnering closely with cross-functional teams. Key Responsibilities <ul><li>Own and maintain design control processes in compliance with ISO 13485, EU MDR, and FDA 21 CFR 820.</li><li>Ensure complete and compliant Design History Files (DHF) and design documentation.</li><li>Lead risk management activities in accordance with ISO 14971.</li><li>Oversee design verification and validation, including usability engineering where applicable.</li><li>Support design transfer to manufacturing and related validation activities.</li><li>Provide design assurance input to design changes, CAPAs, complaints, and post-market activities.</li><li>Support regulatory submissions and audits (Notified Body, FDA, internal).</li></ul>Qualifications & Experience <ul><li>Bachelor’s degree in Engineering, Science, or related field.</li><li>5 years experience in design assurance, quality, or regulatory roles within the medical device industry.</li><li>Strong working knowledge of ISO 13485, ISO 14971, EU MDR, and FDA design controls.</li><li>Experience supporting audits and regulatory submissions.</li></ul>Key Skills <ul><li>Strong attention to detail and documentation skills</li><li>Effective cross-functional communication</li><li>Risk-based decision making</li><li>Ability to work independently in a regulated environment</li></ul>

Design Assurance Manager

Mechanical Engineer – Galway A leading provider of materials handling and advanced automation solutions is seeking a highly skilled Senior Mechanical Engineer to drive the design, development delivery of innovative mechanical systems within turnkey automation projects. The ideal candidate will bring strong technical expertise, exceptional problem-solving ability, and a commitment to engineering excellence. Key Responsibilities: <ul><li>Lead the mechanical design of automated machinery, materials handling equipment, and custom-engineered solutions.</li><li>Produce high-quality 3D models, detailed manufacturing drawings, and technical documentation.</li><li>Perform engineering calculations, tolerance analysis, material selection, and design validation.</li><li>Collaborate with electrical, controls, manufacturing, and project management teams to ensure successful project execution.</li><li>Support concept development, feasibility studies, and cost estimation for new opportunities.</li><li>Provide technical leadership and mentorship to junior engineers and designers.</li><li>Conduct design reviews, risk assessments, and ensure compliance with relevant standards and safety regulations.</li><li>Engage with suppliers and fabrication partners to optimize manufacturability and quality.</li><li>Support equipment installation, commissioning, and troubleshooting when required.</li><li>Drive continuous improvement of engineering processes, tools, and best practices.</li></ul> Required Skills & Experience: <ul><li>Bachelor’s degree in Mechanical Engineering (Master’s preferred).</li><li>5 years of mechanical design experience within automation, machinery, materials handling, robotics, or related fields.</li><li>Will also consider candidates with 2 to 3 yrs experience for another role.</li><li>Expert proficiency with CAD software (e.g., SolidWorks, Inventor, or equivalent).</li><li>Strong understanding of mechanical systems, kinematics, pneumatics, hydraulics, and structural design.</li><li>Proven ability to lead design projects from concept through completion.</li><li>Experience with manufacturing processes such as machining, fabrication, and assembly.</li><li>Excellent analytical, problem-solving, and communication skills.</li><li>Ability to manage multiple projects in a fast-paced environment.</li></ul> Desirable Qualifications: <ul><li>Experience with automation integration and motion systems.</li><li>Knowledge of FEA, simulation tools, and optimization techniques.</li><li>Familiarity with CE/UL standards and machinery safety regulations.</li><li>Hands-on involvement with on-site installation or commissioning.</li><li>Project management experience or relevant certification.</li></ul> For a confidential conversation about the role please apply for the role or contact Gerard Cunniffe at gcunniffe@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose.

Mechanical Engineer

Job Summary: We are seeking a professionally qualified Management Accountant to join our clients manufacturing plant. The ideal candidate will have significant experience in cost accounting, budgeting and financial analysis within a manufacturing environment. You will play a key role in supporting management decision-making by providing accurate and timely financial information, cost control insights, and operational reporting. Key Responsibilities: <ul><li>Prepare and analyze monthly, quarterly and annual management accounts for the plant, highlighting variances and trends.</li><li>Develop and maintain costing models for products, processes and projects, including standard costing and variance analysis.</li><li>Monitor and control plant operating costs, identifying areas for efficiency improvements and cost reduction.</li><li>Prepare and manage budgets, forecasts and financial plans, liaising closely with production, procurement, and supply chain teams.</li><li>Provide financial insights and recommendations to support strategic decision-making and operational improvements.</li><li>Conduct profitability analysis by product line, department, and customer segment.</li><li>Ensure compliance with company policies, internal controls, and accounting standards (e.g., IFRS or GAAP).</li><li>Assist in the preparation of financial reports for senior management and stakeholders.</li><li>Collaborate with external auditors during annual audits and tax reviews.</li></ul> Qualifications and Experience: <ul><li>Professional accounting qualification (e.g., ACCA, CIMA, ACA, CPA).</li><li>Proven experience as a Management Accountant in a manufacturing environment (typically 3–5 years or more).</li><li>Strong understanding of cost accounting, inventory valuation, and manufacturing processes.</li><li>Advanced proficiency in ERP systems (e.g., SAP, Oracle, Microsoft Dynamics) and Excel.</li><li>Excellent analytical, problem-solving, and communication skills.</li><li>Ability to work independently, prioritize tasks, and meet deadlines in a fast-paced environment.</li></ul> For a confidential conversation about the role please apply for the role or 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.

Management Accountant

OPERATIONAL EXCELLENCE SPECIALIST Reporting to: Supply Chain & Business Systems Manager Job Summary: The Operational Excellence (OpEx) Specialist supports the implementation of Lean Six Sigma and Continuous Improvement programmes across the organisation. This role works closely with internal change agents and cross-functional teams to identify improvement opportunities that reduce operating costs, improve efficiency, and enhance service and quality performance. The OpEx Specialist also supports the planning and execution of improvement initiatives to ensure sustainable business results. Key Responsibilities:<ul><li>Execute continuous improvement initiatives across the organisation to meet service, quality, and cost objectives.</li><li>Support excellence in day-to-day business management through the implementation and maintenance of daily management tools.</li><li>Partner with functional leaders and assigned teams to develop strategic project portfolios and detailed project plans.</li><li>Establish and maintain a network of change agents and act as the focal point for continuous improvement expertise and problem-solving across all support functions.</li><li>Apply Lean, Continuous Improvement, and Six Sigma concepts, tools, and training techniques.</li><li>Influence and motivate senior management to identify opportunities and apply Lean, Continuous Improvement, and Six Sigma methodologies.</li><li>Support and motivate project teams to ensure the timely and successful delivery of improvement projects.</li><li>Provide regular and clear communication on project status to departmental staff and leadership.</li><li>Lead education and training activities in partnership with the OpEx team.</li><li>Comply with all EHS policies and procedures and demonstrate best practices in all work activities.</li><li>Maintain awareness of personal safety and the safety of others, complying with all safety notices and barriers.</li><li>Immediately report any EHS incidents or Near Misses (unsafe acts or conditions) to your supervisor and log the event in eAchieve.</li><li>Support a culture of EHS excellence by recognising and submitting opportunities for EHS improvement through eAchieve.</li><li>Attend all required EHS training and medical surveillance programmes.</li><li>Wear appropriate PPE as required.</li></ul> Qualifications, Skills & Experience:<ul><li>Bachelor’s degree required; preferred disciplines include Sciences, Engineering, Operations, Supply Chain Management, or Business Management.</li><li>1–3 years of relevant job-related experience.</li><li>Lean Six Sigma Green Belt or Yellow Belt certification is desirable.</li><li>Experience working in a fast-paced manufacturing environment is an advantage.</li><li>Strong organisational and planning skills.</li><li>Proven ability to prioritise and manage multiple tasks simultaneously.</li><li>Excellent interpersonal and communication skills.</li><li>High level of accuracy with strong attention to detail.</li><li>Strong teamwork and collaboration skills.</li><li>Demonstrated initiative and innovation to generate and implement improvements.</li></ul> For a confidential conversation about the role please apply for the role or contact Gerard Cunniffe at gcunniffe@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose.

Operational Excellence Specialist

Job Title: Device Technician Job Summary: Work as part of a production/operations team, ensuring equipment, work areas, and materials are prepared and operations run safely and efficiently, in line with regulatory and organizational standards. Shift Flexibility: <ul><li>Day: Mon–Fri, 08:00–16:30 (Fri finish 15:30), 39 hours/week</li><li>Evening: 16:00–00:00 (Fri finish 23:00), 16.7% shift allowance</li><li>Night: 00:00–08:00 (Fri finish 07:00), 27% shift allowance</li></ul> Key Responsibilities: <ul><li>Prepare and operate moulding, automated assembly, pad printing, and manual assembly equipment</li><li>Troubleshoot day-to-day manufacturing issues affecting safety, quality, or efficiency</li><li>Conduct quality checks and achieve production targets</li><li>Supply materials safely and on time; label and pack components and finished products</li><li>Operate advanced metrology equipment and robotic/vision systems</li><li>Participate in new product introductions, improvement projects, and continuous improvement initiatives</li><li>Document activities according to GMP standards</li><li>Cross-train team members and assist in onboarding new staff</li><li>Perform manual assembly and visual inspections as needed</li></ul> Essential Qualifications & Skills: <ul><li>Leaving Certificate or equivalent, or relevant work experience</li><li>Minimum 1 year experience in a regulated manufacturing environment</li><li>Basic knowledge of Microsoft Office</li></ul>Desirable: <ul><li>3rd level education</li></ul> For a confidential conversation about the role please apply for the role or 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.

Device Technician

Job Title: Warehouse Operator Job Purpose: The Warehouse Operator is responsible for managing the flow of materials within the warehouse, ensuring accurate receipt, storage, handling, issuance, and shipping of materials in accordance with company procedures and regulatory requirements. *Evening shift : 16:00 – 00:00 Mon to Thurs, 15:00 – 23:00 Fri.* Key Responsibilities: <ul><li>Maintain a clean, organized, and safe work area.</li><li>Receive materials accurately and in a timely manner.</li><li>Ensure all materials are properly located and controlled, both physically and within the warehouse management system (e.g., SAP).</li><li>Issue materials to manufacturing or packaging as required.</li><li>Prepare shipments of product and non-inventory items according to standard operating procedures (SOPs).</li><li>Perform area verifications, including returns, staging, and fixed bin checks, in accordance with SOPs and regulatory standards (cGMP).</li><li>Complete all required documentation associated with the supply and movement of materials.</li><li>Follow all departmental SOPs and current Good Manufacturing Practices (cGMP).</li><li>Stay current with new or revised SOPs and complete required training in safety and cGMP procedures.</li><li>Support warehouse tasks that align with business objectives and ensure on-time delivery to customers.</li></ul> Qualifications & Experience: <ul><li>Leaving Certificate or equivalent.</li><li>Minimum of 3 years’ experience in a warehouse environment; experience in a regulated or pharmaceutical environment preferred.</li><li>Strong safety awareness within a regulated environment.</li><li>Proficient in computer applications such as Outlook, Microsoft Excel, Word, and PowerPoint.</li><li>Good knowledge of warehouse processes and systems (e.g., SAP).</li><li>Experienced forklift operator.</li></ul> Key Competencies: <ul><li>Strong organizational and planning skills.</li><li>Ability to make decisions independently and use initiative.</li><li>Excellent communication and relationship-building skills.</li><li>Adaptable and able to work in a dynamic environment.</li><li>High attention to detail and commitment to accuracy.</li><li>Ability to receive feedback constructively and work collaboratively.</li><li>Driven to achieve results and deliver tasks efficiently under pressure.</li></ul> For a confidential conversation about the role please apply for the role or 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.

Warehouse Specialist

NPI Compliance Specialist (Biologics) Department: Quality Assurance Reporting to: NPI Compliance Manager We are currently recruiting for an experienced NPI Compliance Specialist (Biologics) to support the successful transfer and commercialization of new biologic products at a regulated manufacturing site. This role plays a critical part in ensuring new products are integrated into the site Quality Management System in full compliance with regulatory and company requirements. Key Responsibilities<ul><li>Ensure new products transferred to the site are manufactured in compliance with applicable regulatory requirements, internal policies, and quality standards.</li><li>Maintain the effectiveness of quality system integration for all new product introductions.</li><li>Support new product transfers from development through commercialization, working closely with internal and external cross-functional teams to identify and mitigate quality risks.</li><li>Provide quality direction and subject matter expertise throughout technology and product transfer activities.</li><li>Support vendor evaluation and approval processes, including the initiation, review, approval, and maintenance of technical agreements.</li><li>Review and approve NPI-related analytical test method transfers and/or validation activities.</li><li>Coordinate site review of new product-related material specifications, including raw materials, excipients, in-process, BDS, and drug product specifications.</li><li>Support the management of new product-related exceptions, including the development of corrective and preventative actions (CAPAs).</li><li>Generate and maintain product transfer documentation to support stage gate reviews and commercialization readiness.</li><li>Act as the quality subject matter expert during internal audits and external regulatory inspections related to new products and technology transfers.</li><li>Collaborate closely with QA, CMC, R&D, Science & Technology, and other functional groups to ensure clarity of roles, responsibilities, and compliance expectations.</li><li>Adhere to and actively support all EHS and environmental standards, procedures, and policies.</li></ul> Requirements<ul><li>Third-level qualification in Science, Quality, Engineering, or a related discipline.</li><li>Minimum of 3 years’ experience in a quality role supporting New Product Introduction (NPI) within a regulated pharmaceutical or biologics environment.</li><li>Strong working knowledge of regulatory requirements (GMP, quality systems, and compliance expectations).</li><li>Experience supporting product or technology transfers from development through commercialization.</li><li>Excellent cross-functional communication and stakeholder management skills.</li></ul>Desirable<ul><li>Experience working in an aseptic manufacturing or biologics environment.</li><li>Prior quality experience supporting analytical method transfer and validation activities.</li></ul> For a confidential conversation about the role please apply for the role or 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.

NPI Compliance Specialist (Biologics)

About the jobWe are seeking a Visual Inspection Engineer to support and lead visual inspection operations within a regulated pharmaceutical manufacturing environment. This role plays a key part in ensuring compliance with safety, quality, and regulatory standards while driving continuous improvement across inspection processes, equipment, and personnel certification. The successful candidate will work cross-functionally with Operations, Engineering, and Quality teams and contribute throughout the full project lifecycle, from validation to commercial manufacturing. Key Responsibilities: <ul><li>Act as a core team member supporting Visual Inspection operations in compliance with safety, regulatory, and organizational requirements</li><li>Develop, review, and modify procedures to support manufacturing and inspection activities</li><li>Participate in and support process, equipment, and facility validation activities</li><li>Review, approve, and execute commissioning, qualification, and validation protocols</li><li>Lead and participate in Process FMEAs related to Visual Inspection</li><li>Establish, lead, and optimize technician certification programs for visual inspection</li><li>Establish and maintain a Visual Inspection defect library</li><li>Develop and execute defect trending and data analysis processes</li><li>Ensure site Visual Inspection procedures align with global guidance documents and regulatory expectations</li><li>Provide technical input into SOP development and continuous improvement initiatives</li><li>Lead manufacturing and validation activities across the project lifecycle</li><li>Coordinate with internal and external stakeholders for particle and defect evaluation</li><li>Support technical transfers and future product introductions</li><li>Investigate process deviations, exceptions, and equipment malfunctions</li><li>Liaise with Engineering and Quality teams as required</li><li>Support production to ensure processes meet output, yield, and quality targets</li></ul> Essential Requirements: <ul><li>Degree (or higher) in Engineering, Science, or a related technical discipline</li><li>Minimum 3 years’ experience in Technical, Operations, Manufacturing, or Quality roles within a pharmaceutical, biotechnology, or healthcare environment</li><li>Minimum 3 years’ experience in a regulated manufacturing environment</li></ul> Experience with parenteral or biotechnological drug manufacturing is highly desirable, including: <ul><li>Fill & Finish</li><li>Aseptic processing</li><li>Lyophilisation</li><li>Sterilisation operations</li><li>Experience with clean utilities is an advantage</li></ul> For a confidential conversation about the role please apply for the role or 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

Production Manager We are seeking an experienced Production Manager to lead and coordinate site-wide production planning and execution within a fast-paced manufacturing environment. This role is responsible for managing cross-functional teams, optimising resources, and ensuring production schedules align with customer, quality, and business requirements. Key Responsibilities<ul><li>Lead a multi-functional team to plan, manage, and execute production schedules across the site</li><li>Manage human and material resources to consistently meet production targets</li><li>Provide accurate estimated production dates to Quality and other stakeholders to support scheduling activities</li><li>Liaise closely with Engineering and Purchasing regarding Engineering Change Notices (ECNs), advising on part revisions and ordered components</li><li>Review, adjust, and communicate production schedules as business needs change</li><li>Prioritise and expedite urgent or short-lead-time requirements outside standard planning cycles</li><li>Ensure full traceability of parts throughout the production process</li><li>Ensure Standard Operating Procedures (SOPs) are adhered to at all times</li><li>Monitor Health & Safety compliance, recommending and implementing improvements where agreed</li><li>Capture and analyse capacity data across the product range to continuously improve the planning process</li><li>Conduct regular performance review meetings with Supervisor teams to track targets, issues, and improvements</li><li>Prepare, maintain, and present weekly production performance reports to management</li><li>Support and participate in organisational structure development to meet evolving site demands</li><li>Delegate tasks effectively in line with the organisational structure</li><li>Performance manage, coach, develop, and motivate team members</li><li>Drive a consistent systems-based and continuous improvement mindset across the organisation</li><li>Improve product flow through the site using Lean Manufacturing principles</li><li>Travel nationally and internationally as required</li></ul>Education & Experience<ul><li>Degree in a relevant discipline such as Engineering, Manufacturing, or Science</li><li>Minimum of 5 years’ experience in a similar production planning or manufacturing leadership role</li><li>Experience working within an ISO-certified environment (aviation or regulated industry experience is advantageous but not essential)</li><li>Strong understanding and practical experience implementing Lean Manufacturing techniques</li><li>Experience working with ERP / MRP systems</li><li>Excellent project management and organisational skills</li></ul> For a confidential conversation about the role please apply for the role or 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.

Production Manager

Manufacturing Project Engineer (12-Month Contract) Location: County Cork, Ireland Company Overview: A leading global medical device company based in County Cork is seeking a Manufacturing Project Engineer on a 12-month contract. The role will focus on supporting regulatory compliance, validation, change control, and project execution in a fast-paced manufacturing environment. Key Responsibilities: <ul><li>Regulatory Compliance: Ensure adherence to medical device regulations (ISO 13485, FDA, MDR) in manufacturing processes.</li><li>Validation: Lead and execute validation activities (IQ/OQ/PQ) for equipment, processes, and systems.</li><li>Change Control: Oversee and support change control processes, ensuring proper documentation and approval.</li><li>Project Execution: Assist in managing project tasks, timelines, and deliverables, working with cross-functional teams.</li><li>Documentation: Maintain clear documentation for validation, change control, and project progress.</li></ul>Required Skills and Experience: <ul><li>3 years of experience in medical device manufacturing, including regulatory compliance and validation.</li><li>Strong knowledge of FDA, ISO 13485, and EU MDR regulations.</li><li>Experience in change control processes and project task execution.</li><li>Excellent attention to detail, communication, and problem-solving skills.</li><li>Ability to work in a cross-functional team and manage multiple priorities.</li></ul>Contract Duration: 12 months, with potential for extension. Application Process: Please submit your CV and cover letter outlining relevant experience.

Manufacturing Project Engineer

Role Overview We are seeking a driven and analytical Accountant II to partner with a high-performing manufacturing operation. This role works closely with operations teams to monitor financial performance, analyse variances, and provide insights that support cost control, efficiency improvements, and operational excellence. The ideal candidate will have strong manufacturing finance experience, enjoy working cross-functionally, and be motivated by data-driven performance improvement. Key Responsibilities: <ul><li>Evaluate production performance on a daily basis, including labour efficiency and waste metrics, ensuring data integrity and following up on variances.</li><li>Partner closely with operations teams to provide financial insight and support delivery of performance targets.</li><li>Analyse financial data and trends to identify process improvements and cost efficiencies.</li><li>Prepare and present reports to help operations manage labour, material, and overhead costs.</li><li>Support month-end reporting, providing accurate analysis of material, labour, and overhead variances versus plan.</li><li>Maintain strong inventory controls.</li><li>Assist with the preparation of the Annual Operating Plan (AOP) and quarterly forecast reviews.</li><li>Participate in continuous improvement initiatives, representing finance at tier meetings and problem-solving sessions.</li><li>Collaborate with operations to ensure integrity of MRP systems, bills of materials, inventory valuation, and subcontracting setups.</li><li>Support cost improvement projects by evaluating financial impact, forecasting savings, and tracking results.</li><li>Maintain and update standard costs to ensure accuracy and timeliness.</li><li>Review monthly volume forecasts and assess labour requirements to support production demand.</li><li>Perform ad-hoc financial modelling, cost comparisons, and analytical projects as required.</li><li>Ensure compliance with internal policies and external accounting standards.</li></ul> Experience & Qualifications: <ul><li>2–5 years’ experience in a manufacturing finance environment.</li><li>Hands-on experience with standard costing is essential.</li><li>Bachelor’s degree or diploma in Finance, Accounting, Economics, or a related discipline.</li><li>Professional accounting qualification (CIMA / ACCA / ACA or equivalent) is desirable but not essential.</li></ul> Skills & Technical Requirements: <ul><li>Advanced Microsoft Excel skills.</li><li>Experience with ERP systems</li><li>Power BI or similar reporting tools are desirable.</li><li>Strong analytical, communication, and presentation skills.</li></ul> For a confidential conversation about the role please apply for the role or 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.

Accountant II

Lead R&D Engineer Location: Co. Mayo, Ireland Overview Seeking an experienced R&D professional to drive early-stage innovation and develop new product concepts and technologies. The role involves leading and supporting cross-functional teams from clinical need through to concept and prototype development. Key Responsibilities <ul><li>Translate clinical needs into device concepts and prototypes in line with human factors and regulatory requirements.</li><li>Research and evaluate new technologies to enhance the product portfolio.</li><li>Provide technical support to NPD, Marketing, Engineering, and Manufacturing teams.</li><li>Lead or support cross-functional project teams.</li><li>Manage project schedules, risks, and deliverables.</li><li>Prepare financial justifications for project approvals.</li><li>Review vendor offerings and source materials/components.</li><li>Support product introductions, trials, and patent activities.</li></ul>Requirements <ul><li>8 years’ industry experience, preferably in medical devices.</li><li>Bachelor’s degree in Biomedical Engineering or related discipline (Master’s/PhD preferred).</li><li>Strong innovation, analytical, and problem-solving skills.</li><li>Experience with human factors, product design, and prototyping.</li><li>Good knowledge of medical device regulations and quality systems.</li><li>Strong communication, organisation, and teamwork skills.</li><li>SolidWorks/3D modelling experience (preferred).</li><li>Fluent in English (written and spoken).</li></ul>

Lead R&D Engineer

Job Title:    CNC Programmer Location:    Limerick Status:      Permanent Position Summary: <ul><li>The role of CNC Programmer involves programming, setting up, and operating CNC and Swiss-type sliding head machines.</li><li>Strong hands-on expertise with Swiss-type machines, and proficiency in CNC, 5-axis, and mill-turn programming. The company offers a cutting-edge R&D environment, career development opportunities and an entrepreneurial, team-focused culture</li></ul>Key Responsibilities: <ul><li>Collaborate on process development for new and complex components, working closely with engineering teams.</li><li>Optimise CNC programs and processes to achieve production efficiency while maintaining the highest quality standards</li><li>Take ownership of projects, ensuring production goals are met and maintaining strong client satisfaction.</li></ul>  Qualifications and Requirements: <ul><li>Experience in programming machines essential</li><li>5 years’ experience in a similar CNC Operator type role.</li><li>Experience in 5 axis programming and mill turn programming</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

CNC Programmer

Senior Program Manager – Medical Devices Location: Mayo Overview This is a pivotal leadership role at the centre of a global innovation organisation. The Senior Program Manager will lead highly complex, cross-functional programs that directly impact product portfolios, business performance, and patient outcomes. This role requires strong program leadership, systems thinking, and the ability to drive predictable execution across technical and commercial teams. It is highly visible, with regular interaction at senior and executive leadership levels. Key Responsibilities <ul><li>Lead one or more strategically critical, enterprise-level programs from concept through delivery</li><li>Translate strategic goals into integrated, portfolio-aligned program plans</li><li>Orchestrate cross-functional teams across Engineering, Operations, Quality, Regulatory, Clinical, and Marketing</li><li>Manage interdependencies, risks, resources, and timelines to ensure predictable execution</li><li>Provide clear, data-driven insights to support senior decision-making</li><li>Communicate program status, risks, and trade-offs with clarity and authority</li><li>Coach teams and contribute to continuous improvement of program management standards</li></ul>What Success Looks Like <ul><li>Delivers consistent outcomes in complex, regulated environments</li><li>Anticipates risks and drives proactive decision-making</li><li>Influences effectively across functions and leadership levels</li><li>Balances strategic thinking with operational discipline</li></ul>Requirements <ul><li>8–10 years’ experience in senior program or core team leadership roles</li><li>Proven success delivering complex product development programs in regulated environments (medical devices preferred)</li><li>Strong systems thinking, risk management, and stakeholder influencing skills</li><li>Experience with Stage-Gate and Project Portfolio Management (PPM)</li><li>Excellent communication and executive-level reporting capability</li><li>PMP or equivalent certification preferred</li><li>Bachelor’s degree in a technical discipline (advanced degree advantageous)</li><li>Ability to travel up to 10%</li><li>Experience working in a hybrid environment</li></ul>

R&D Program Manager

Senior Manufacturing Engineer Role Overview As a Senior Manufacturing Engineer, you will play a leading role within a multidisciplinary engineering team, driving the development and advancement of catheter-based medical device technologies. This position focuses on technology advancement from early concept through verification and validation, including the development of new manufacturing processes, device concepts, and production methods. You will have significant technical ownership and influence across both manufacturing engineering and device design and development, as well as the opportunity to mentor others and shape best practices. Key Responsibilities <ul><li>Lead and own the development of new and improved manufacturing methods for catheter-based devices</li><li>Serve as a technical expert in catheter manufacturing processes, materials, and prototyping techniques</li><li>Rapidly prototype device and fixture concepts in-house using standard catheter manufacturing equipment and 3D printing technologies</li><li>Perform mechanical modeling and analysis using SolidWorks or equivalent CAD tools</li><li>Design, develop, and optimize robust manufacturing processes suitable for scale-up and commercialization</li><li>Design fixtures and test models for proof-of-concept, verification, and validation activities</li><li>Lead the design, build, and documentation of novel neurovascular catheter technologies</li><li>Drive and support verification and validation efforts for new product designs and manufacturing processes</li><li>Develop and manage project plans, technical specifications, timelines, and deliverables</li><li>Identify, evaluate, and manage external vendors for materials, processes, and manufacturing equipment</li><li>Contribute to and support the generation of intellectual property, including invention disclosures and patent filings</li><li>Provide technical guidance and mentorship to junior engineers and cross-functional team members</li></ul>Required Qualifications <ul><li>Bachelor’s degree in Engineering or a related discipline</li><li>Minimum of 5 years’ experience in the medical device industry, ideally with catheter-based technologies</li><li>Demonstrated hands-on mindset with a strong track record of practical problem solving</li><li>Proven ability to rapidly prototype device and fixture concepts using catheter manufacturing techniques and 3D printing</li><li>Advanced proficiency in mechanical modeling and analysis using SolidWorks or similar CAD tools</li><li>Strong experience working with medical-grade polymers and materials</li><li>Deep understanding of manufacturing process development, verification, validation, and implementation</li><li>Excellent verbal and written communication skills, with the ability to engage effectively across technical and non-technical teams</li><li>Experience working in dynamic, fast-paced development environments</li><li>Commitment to continuous professional development and staying current with catheter design, materials, and prototyping techniques</li></ul>

Senior Manufacturing Engineer

We are actively seeking a Financial Analyst to provide financial support to our client located in County Mayo. This role reports to the Senior Manager Finance, Global Supply Chain and acts as a key finance partner to the local Distribution leadership team. This is an excellent opportunity for a commercially minded finance professional to work closely with operations, support decision-making, and drive performance in a fast-paced, multinational environment. Key Responsibilities:  Business Partnering & Reporting <ul><li>Act as the key finance partner to the Distribution Center leadership team</li><li>Prepare, review, and present monthly financial performance results and key metrics</li></ul>Planning, Forecasting & Analysis <ul><li>Own and prepare the Annual Operating Plan (AOP)</li><li>Develop and maintain rolling forecasts for the Distribution Center</li><li>Build future cost models to support strategic and operational decisions</li></ul>Inventory & Cost Management <ul><li>Partner with Distribution teams to control inventory and manage obsolescence</li><li>Coordinate assignment of inventory risk to responsible parties</li><li>Identify, quantify, and track cost-saving opportunities</li></ul>Compliance & Controls <ul><li>Collaborate with internal and external auditors, providing analysis and documentation as required</li><li>Ensure compliance with all relevant financial rules, regulations, and policies</li></ul>Capital & Projects <ul><li>Evaluate capital expenditure requests for the Distribution Center</li><li>Act as Finance Lead for Distribution within transformation initiatives, including S/4HANA implementation</li><li>Lead or support ad-hoc finance projects as required</li></ul>Analytics & Systems <ul><li>Develop analytical models and dashboards using available tools (e.g. Excel, Power BI, AI tools)</li></ul>Experience & Qualifications Work Experience <ul><li>2–5 years of relevant finance experience</li><li>Ideally 3 years post-qualification experience</li><li>Background in a multinational environment preferred</li><li>Experience within distribution, manufacturing, or shared services is an advantage</li></ul>Education <ul><li>Bachelor’s degree in Finance, Accounting, Economics, or a related field</li><li>Professional accounting qualification desirable but not mandatory (CIMA, ACCA, ACA, or equivalent)</li></ul>Technical Skills <ul><li>Advanced MS Excel skills</li><li>SAP experience desirable</li><li>Power BI knowledge is a plus</li></ul> For a confidential conversation about the role please apply for the role or 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.

Financial Analysis

Job Title: Engineering Manager Location:    Clare Status:     Permanent Position Summary We are seeking an experienced Engineering Manager to lead and scale a fast-growing, multidisciplinary engineering organization focused on developing next-generation products. This role oversees teams across hardware, embedded software, and mechanical engineering, and works closely with product, manufacturing, and quality organizations to deliver innovative, high-quality products from concept through mass production. The Engineering Manager is accountable for product delivery and for ensuring engineering execution aligns with the company’s strategic vision and technology roadmap. The successful candidate will play a key role in shaping organizational growth by driving team structure, process maturity, and technical excellence, while maintaining a strong partnership with our on-site manufacturing facility. Key Responsibilities <ul><li>Lead, mentor, and grow a multidisciplinary engineering organization across hardware, embedded software, and mechanical engineering, in collaboration with functional lead developers.</li><li>Define clear roles, responsibilities, and career development paths that support both technical and managerial growth.</li><li>Partner with the PMO and project management teams to successfully deliver multiple concurrent projects, balancing scope, quality, cost and schedule.</li><li>Build and evolve a scalable engineering organization capable of supporting increasing product diversity and technical complexity.</li><li>Communicate engineering status, risks, challenges, and achievements to senior leadership and key stakeholders.</li><li>Prepare and present technical reports, resource plans, capacity forecasts and long-term engineering roadmaps.</li></ul>Qualifications and Requirements <ul><li>8 years of engineering experience in product development, including 5 years in an engineering leadership or management role overseeing teams of 30 engineers.</li><li>Demonstrated success leading and developing cross-disciplinary teams in hardware and software product environments.</li><li>Proven track record of delivering complex engineering projects on time and within budget.</li><li>Experience driving product performance, quality and manufacturability metrics.</li><li>Strong focus on team engagement, retention and professional growth.</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 Manager

Job Title:    Validation Engineer Location:    Galway Status:      Permanent Position Summary: <ul><li>This is an exciting opportunity to contribute to a growing, collaborative environment where your expertise helps drive operational excellence and regulatory compliance.</li><li>Reporting to the Validation Team Lead, you’ll help implement the Validation Master Plan, maintain SOPs, execute validation activities across processes, cleaning, equipment, analytical instruments and utilities.</li></ul>    Key Responsibilities: <ul><li>Maintain accurate, audit-ready validation documentation in line with SOPs and regulatory requirements</li><li>Ensure all validation activities comply with GMP, regulatory guidelines, and internal procedures.</li><li>Collaborate closely with manufacturing, quality, engineering, and analytical teams to coordinate validation activities.</li><li>Support technology transfers and new product introductions through effective validation planning and execution.</li></ul> Qualifications and Requirements: <ul><li>Strong knowledge of GMP and validation principles.</li><li>2 years’ experience in validation within a GMP-regulated environment</li><li>Ability to maintain audit-ready records and ensure accuracy and completeness in validation documentation.</li><li>Degree in Engineering, Pharmaceutical Science, or a related discipline</li></ul>    For a confidential conversation about the position 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

Validation Engineer

Job Title:    Validation Team Lead Location:    Galway Status:      Permanent Position Summary: <ul><li>This is an exciting opportunity to shape validation excellence in a growing, high-performing environment.</li><li>We’re looking for a dynamic Validation Team Lead to take ownership of our site’s validation strategy and ensure full compliance with regulatory and company standards.</li><li>In this key leadership role, you’ll guide the Validation function, manage the Validation Master Plan and oversee critical validation activities across processes, cleaning, equipment, analytical instruments and utilities.</li></ul>  Key Responsibilities: <ul><li>Oversee process validation for both new and existing products, including protocol development and execution.</li><li>Manage cleaning validation programs to safeguard product integrity and mitigate cross-contamination risks.</li><li>Lead, mentor, and develop the Validation team to drive strong performance and engagement.</li><li>Prioritise and allocate resources effectively to meet business goals and compliance requirements.</li><li>Ensure timely completion and approval of validation protocols, reports, and documentation.</li><li>Provide validation support for technology transfers and new product introductions.</li></ul> Qualifications and Requirements: <ul><li>Deep understanding of GMP and relevant regulatory requirements.</li><li>Strong leadership, communication, and organisational skills.</li><li>Hands-on experience across process, cleaning, equipment, and utilities validation</li><li>A commitment to excellence in compliance and documentation. </li></ul>For a confidential conversation about the position 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

Validation Lead

Finance Business Partner (Cost Accounting)  We are seeking a Finance Business Partner (Cost Accounting) to lead the management accounting function and provide critical financial insights that drive operational efficiency and profitability within a fast-paced manufacturing environment. In this senior role, you will partner closely with Production, Supply Chain, Finance, and cross-functional teams to ensure accurate cost information, effective cost control, and continuous improvement across the organisation. Key Responsibilities; Management Accounting <ul><li>Oversee all cost accounting activities, including standard costing, inventory valuation, and cost variance analysis.</li><li>Maintain and enhance cost accounting systems to ensure accurate and timely reporting.</li><li>Prepare monthly, quarterly, and annual cost reports for leadership review.</li></ul>Cost Analysis & Reporting<ul><li>Analyse production costs, overheads, and key cost drivers.</li><li>Deliver insights on cost trends, product profitability, and operational performance.</li><li>Develop and monitor KPIs focused on cost management and operational efficiency.</li><li>Conduct variance analysis and present findings with actionable recommendations.</li><li>Work collaboratively with department heads to monitor and manage cost performance.</li></ul>Process Improvement<ul><li>Identify opportunities for cost reduction, process optimisation, and improved data accuracy.</li><li>Lead initiatives to automate and streamline cost accounting and reporting workflows.</li><li>Partner with IT and Finance on system enhancements and efficiency projects.</li></ul>Team Leadership<ul><li>Lead, mentor, and develop a high-performing cost accounting team.</li><li>Foster a culture of accountability, collaboration, and continuous improvement.</li><li>Drive cross-functional efforts to support company-wide cost optimisation initiatives.</li></ul>Additional Responsibilities<ul><li>Support annual budgets, rolling forecasts, and long-term financial planning.</li><li>Ensure accurate inventory valuation, including standard and actual cost of goods sold.</li></ul>Education & Experience<ul><li>Bachelor’s degree in Accounting or Finance.</li><li>Professional accounting qualification (ACA/CPA, CIMA, ACCA).</li><li>5 years' experience in cost accounting or financial analysis, ideally in a GMP manufacturing or production environment.</li><li>Strong understanding of standard costing, activity-based costing, and variance analysis.</li><li>Proficiency with ERP systems (e.g., SAP, Oracle).</li></ul>Skills & Competencies<ul><li>Advanced Excel and strong data analysis skills.</li><li>Excellent analytical, communication, and problem-solving capabilities.</li><li>High attention to detail with the ability to meet tight deadlines.</li><li>Strategic thinker with the ability to turn data into actionable insight.</li><li>Strong leadership and team management skills.</li><li>Proven ability to work effectively with cross-functional teams.</li></ul> For a confidential conversation about the role please apply for the role or 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.

Finance Business Partner - Cost Accounting 

About the Role We are seeking an experienced Operations Aseptic Specialist to join our Aseptic Manufacturing team. The successful candidate will serve as a Subject Matter Expert (SME) in aseptic operations, ensuring compliance with regulatory requirements and best practices, driving continuous improvement, and supporting the delivery of sterile products of the highest quality. Key Responsibilities <ul><li>Serve as a site Subject Matter Expert in Aseptic Manufacturing.</li><li>Provide guidance and input for manufacturing process setup and batch records.</li><li>Ensure operational procedures comply with regulatory requirements, safety, environmental regulations, GMP standards, and aseptic best practices.</li><li>Utilize risk management tools (pFMEA, HAZOP, What-If analyses) to drive aseptic performance and sterility assurance.</li><li>Collaborate with Quality, Engineering, and Aseptic teams to support manufacturing shifts and ensure safe, timely, and sterile batch production.</li><li>Observe and provide feedback on aseptic technique and behaviors during critical activities such as cleaning, sanitization, aseptic setup, EM plate handling, and interventions.</li><li>Lead and support investigations into process or product issues related to sterility, media fills, environmental monitoring excursions, and EMPQ, contributing to root cause analysis and CAPA.</li><li>Analyze and trend environmental monitoring (EM) data, maintaining EM visualization tools and implementing action plans to address trends.</li><li>Contribute to the continuous improvement of aseptic procedures and processes by interpreting and applying new regulatory requirements, developing best practices, and supporting site change control processes.</li><li>Provide input on contamination control strategy, aseptic process simulation (APS) strategy, long-range planning related to aseptic manufacturing, and cleanroom/equipment design, qualification, and maintenance.</li><li>Support regulatory audits as a subject matter expert in aseptic manufacturing and sterility assurance.</li><li>Train operations personnel in aseptic techniques and aseptic processing procedures.</li><li>Participate in leadership GEMBAs of manufacturing and testing areas to drive performance and engagement.</li></ul>Qualifications & Experience <ul><li>Third-level degree in Science, Quality, or Engineering discipline.</li><li>Minimum 5 years of experience in a GMP environment, with at least 3 years supporting aseptic manufacturing (non-negotiable).</li><li>Strong knowledge of regulatory requirements, including EU GMP Annex 1, FDA 21 CFR Parts 210, 211, and 610, and relevant guidance documents.</li><li>Expertise in risk management tools that drive aseptic performance, including contamination control strategies, pFMEA, HAZOP, and What-If analyses.</li><li>Experience in tracking, analyzing, and trending environmental monitoring data.</li><li>Proven experience in investigations related to sterility, media fills, EM excursions, and EMPQ, with ability to determine root cause and drive CAPA.</li><li>Excellent communication and interpersonal skills with a focus on collaboration and leadership.</li></ul> For a confidential conversation about the role please apply for the role or 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.

Aseptic Operations Specialist

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

Production Supervisor

About the Role We are seeking an experienced and highly proactive Executive Assistant / Personal Assistant to provide top-tier administrative and operational support to a senior leader within a regulated industry environment. This role requires exceptional organizational skills, strong business judgment, and the ability to anticipate needs in a fast-paced and dynamic setting. The successful candidate will be responsible for comprehensive executive support, project coordination, meeting and event planning, document management, and confidential administrative functions. Key Responsibilities Executive & Administrative Support<ul><li>Provide strategic, high-level administrative support to optimize the executive’s time and ensure effective achievement of priorities.</li><li>Manage complex calendars, schedules, and competing priorities; proactively identify and resolve scheduling conflicts.</li><li>Coordinate domestic and international travel arrangements, including accommodations, itineraries, and expense claims.</li><li>Handle confidential correspondence, prepare business documents, edit presentations, and maintain organized filing systems.</li><li>Streamline expense reporting, manage documentation, and ensure efficient administrative workflows.</li></ul>Project & Meeting Coordination<ul><li>Manage project-based tasks and follow up with staff and senior stakeholders to ensure deliverables and deadlines are met.</li><li>Track priorities and metrics on behalf of the executive.</li><li>Lead meeting preparation, including drafting agendas, tracking attendance, coordinating materials, and taking accurate minutes.</li><li>Monitor and follow up on action items and open issues to ensure timely progress.</li></ul>Event & Logistics Management<ul><li>Support internal capacity-building activities, conferences, and workshops by managing all logistical arrangements.</li><li>Liaise with facilitators, vendors, caterers, and venues as required.</li><li>Create purchase order requests and support the tracking of budget expenditures.</li></ul>Compliance & Stakeholder Management<ul><li>Interact professionally with senior leaders, internal teams, and external partners while managing sensitive and confidential information.</li><li>Maintain departmental files in accordance with corporate policies and regulatory requirements.</li><li>Operate independently with minimal supervision while maintaining a high standard of professionalism.</li></ul>Systems & Tools<ul><li>Use Microsoft Office Suite to prepare reports, presentations, and documents.</li><li>Utilize SAP, SAP Concur, or similar systems for travel, expense, and invoice processing.</li></ul>Requirements<ul><li>Relevant diploma or equivalent professional experience.</li><li>10 years of experience in an Executive Assistant or Personal Assistant role supporting senior leadership.</li><li>Experience in a regulated industry (pharmaceutical preferred but not required).</li><li>Intermediate to advanced proficiency in Microsoft Office Suite.</li><li>Experience with SAP, SAP Concur, or comparable travel/expense/invoice systems.</li><li>Strong organizational, communication, and multitasking skills.</li><li>Ability to work with discretion, independence, and sound judgment.</li></ul> For a confidential conversation about the role please apply for the role or 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.

Executive Assistant

Validation Engineer Reporting To: NPI & Engineering Manager Overview We are seeking an experienced engineer with advanced expertise in metrology and validation to support upcoming New Product Introduction (NPI) projects and the new building expansion. The successful candidate will play a key role in ensuring product and process compliance, supporting facility readiness, and driving continuous improvement in a regulated environment Key Responsibilities Validation <ul><li>Develop and execute comprehensive validation protocols (IQ/OQ/PQ) for equipment, processes, and products, ensuring compliance with industry standards (e.g., ISO 13485, FDA).</li><li>Lead and document validation activities for new product launches, process changes, and facility expansions.</li><li>Collaborate with cross-functional teams (engineering, quality, manufacturing, regulatory) to ensure validation deliverables are met on time and within scope.</li></ul>NPI Project Support <ul><li>Act as a technical expert in metrology and validation during NPI project phases, supporting prototype builds, pilot runs, and full-scale production launches.</li><li>Participate in risk assessments (FMEA), process mapping, and control plan development for new products.</li><li>Ensure facility readiness by coordinating equipment qualification, process validation, and documentation with relevant stakeholders.</li></ul>  Documentation & Compliance <ul><li>Maintain accurate and thorough documentation aligned with regulatory, quality, and company standards.</li><li>Prepare validation reports, inspection records, and change control documentation for audits and regulatory submissions.</li><li>Support internal and external audits, including responding to audit observations and implementing corrective actions.</li></ul>Continuous Improvement <ul><li>Identify and lead process improvement initiatives related to metrology, validation, and NPI activities.</li><li>Provide training and mentorship to junior engineers and technicians on metrology and validation best practices.</li><li>Stay current with emerging technologies, regulatory changes, and industry trends to enhance department capabilities.</li></ul>Qualifications & Experience <ul><li>Bachelor’s or Master’s dree in Engineering (Mechanical, Biomedical, or related discipline).</li><li>Proven experience in metrology techniques and tools (CMM, gauges, calibration).</li><li>Hands-on experience with validation activities (IQ/OQ/PQ) in a regulated environment (medical device, pharma, or similar).</li><li>Strong problem-solving, analytical, and communication skills.</li><li>Experience with quality management systems (ISO 13485, FDA) and regulatory audits.</li><li>Ability to work collaboratively in cross-functional teams and manage multiple projects simultaneously.</li><li>Experience with risk management (FMEA), process mapping, and statistical analysis is highly desirable.</li><li>Flexibility and adaptability to support dynamic project requirements and timelines.</li></ul>

Overview We are seeking an experienced Additive Manufacturing Lead to oversee Laser Powder Bed Fusion (L-PBF) capabilities and drive the successful launch of new additive manufacturing projects from development through high-volume production. This role is ideal for someone with strong technical expertise, a passion for advanced manufacturing technologies, and the ability to thrive in a fast-paced, dynamic environment. Key Responsibilities<ul><li>Act as the technical owner of all Laser Powder Bed Fusion (L-PBF) operations.</li><li>Lead Additive Manufacturing–focused New Product Introduction (NPI) projects.</li><li>Ensure compliance with Health & Safety standards within the additive manufacturing area.</li><li>Manage preventative maintenance scheduling to ensure equipment uptime and reliability.</li><li>Develop and oversee production schedules to meet business and customer requirements.</li><li>Create and execute long-term strategies for scaling to higher-volume AM production.</li><li>Lead process validation activities—including VP, IQ, OQ, PQ—and maintain all required documentation.</li><li>Participate in cross-functional project meetings and timeline reviews.</li><li>Train and mentor manufacturing team members on AM processes and best practices.</li><li>Collaborate with Materials Science, Design Engineering, Quality Assurance, and other departments to deliver high-quality products on schedule.</li><li>Perform additional duties as required to support operational goals.</li></ul> Qualifications & Experience<ul><li>Bachelor’s degree in Industrial Engineering, Mechanical Engineering, or a related discipline.</li><li>Engineering experience within the medical device industry.</li><li>Hands-on experience with Laser Powder Bed Fusion additive manufacturing.</li><li>Knowledge of Lean methodologies (Six Sigma, Kaizen, Kanban, 5S).</li><li>Strong understanding of operations and New Product Introduction (NPI) processes.</li><li>Excellent verbal and written communication skills for working with internal and external stakeholders.</li><li>Self-starter with strong analytical, problem-solving, and multitasking abilities.</li><li>Ability to excel in a dynamic, results-driven, and collaborative environment.</li><li>Demonstrated success in cross-functional teamwork, particularly with Product Development and Quality teams.</li></ul> For a confidential conversation about the role please apply for the role or 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.

Additive Manufacturing Lead

We are seeking an experienced Automation Engineer (NPI) to support manufacturing operations within a GMP pharmaceutical environment. This role will provide technical expertise for control systems, lead automation activities for New Product Introductions (NPIs), and drive continuous improvement initiatives across the facility. Key Responsibilities Control System Support<ul><li>Provide day-to-day technical support for manufacturing control systems, including troubleshooting, patching, optimisation, and stability improvements.</li><li>Support qualification, commissioning, and start-up activities for new equipment and systems.</li><li>Manage the lifecycle of control systems in accordance with GAMP 5 standards.</li></ul>Project & Continuous Improvement<ul><li>Lead and support continuous improvement projects in collaboration with process engineering, technical support, and cross-functional teams.</li><li>Assist in the development of future integrations between control systems, MES, and ERP systems.</li><li>Prepare proposals and recommendations for long-term maintenance, upgrades, and system improvements.</li></ul>Compliance & Standards<ul><li>Ensure adherence to 21 CFR Part 11, EU Annex 11, and other regulatory requirements for automated systems.</li><li>Follow all EHS&E policies, procedures, and best practices.</li></ul>Requirements Education<ul><li>B.Eng degree or Postgraduate Diploma in a relevant technical discipline.</li></ul>Experience & Technical Skills<ul><li>2 years experience in process automation within a GMP pharmaceutical manufacturing environment.</li><li>Experience working with vendor-packaged equipment and automated system compliance requirements.</li><li>Proven experience supporting plant start-ups and/or NPIs, with the ability to lead automation activities.</li><li>Strong experience configuring and troubleshooting: <ul><li>PLC systems</li><li>SCADA/HMI applications</li></ul></li><li>Knowledge of industrial control networks such as Profinet, Profibus, Modbus, CANBus.</li><li>Understanding of Ethernet-based network architecture.</li><li>Experience integrating with plant historians (e.g., Ignition, OSI-PI) using OPC interfaces.</li><li>Strong knowledge of control system lifecycle management including backups, disaster recovery, access control, configuration management, and change control.</li><li>Working knowledge of Windows OS administration.</li></ul> For a confidential conversation about the role please apply for the role or 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.

Automation Engineer

Business Development Executive Overview We’re looking for a dynamic Business Development Executive to drive growth and customer success for our HomeLINK platform. In this role, you’ll champion the adoption of our connected home and IoT solutions among housing providers, property managers, resellers, and key partners. You’ll also play a pivotal part in customer onboarding and act as the bridge between clients and our product team — ensuring customer feedback directly shapes future innovations. Key Responsibilities Business Development<ul><li>Identify, qualify, and nurture new business opportunities across housing associations, local authorities, and residential developers.</li><li>Lead proactive outreach — including email campaigns, calls, and industry networking.</li><li>Deliver engaging, tailored product demonstrations that address stakeholder priorities such as compliance, ESG, and resident wellbeing.</li><li>Develop compelling proposals, respond to tenders, and produce case studies that highlight ROI and impact.</li></ul>Customer Success<ul><li>Manage the onboarding process, ensuring customers are confident in using the HomeLINK dashboard and device features.</li><li>Build lasting client relationships through regular check-ins, usage reviews, and performance insights.</li><li>Monitor customer engagement to identify potential churn risks and growth opportunities.</li><li>Help customers unlock actionable insights from environmental and safety data to drive positive outcomes.</li></ul>Product & Market Insights<ul><li>Capture and communicate customer feedback on usability, functionality, and device performance.</li><li>Partner with product and engineering teams to inform feature development and testing.</li><li>Support pilot projects, user training, and customer enablement materials.</li><li>Stay current with housing regulations, ESG standards, and IoT industry trends to inform strategy and positioning.</li></ul>Skills & Experience Essential<ul><li>2–4 years of experience in B2B sales, business development, or technical account management.</li><li>Demonstrated success managing complex customer relationships and multi-stakeholder accounts.</li><li>Excellent communication and presentation skills, with the ability to engage both technical and non-technical audiences.</li><li>Strong organisational skills and CRM experience (e.g. Salesforce, Dynamics, or similar).</li><li>Passion for connected technology, sustainability, and the future of housing.</li></ul>Desirable<ul><li>Experience in IoT, PropTech, or smart building technology.</li><li>Knowledge of Irish social housing, ESG frameworks, or compliance standards.</li><li>Exposure to product development, customer feedback processes, or agile environments.</li></ul>What You’ll Get<ul><li>Competitive base salary plus performance-related bonus.</li><li>Fully expensed company car.</li><li>Opportunity to work with cutting-edge IoT solutions driving real social impact.</li><li>Collaborative environment with dedicated support from product, engineering, and commercial teams.</li><li>Clear pathways for career growth across sales, customer success, and product functions.</li></ul>

Business Development Executive

Head of Automation - Limerick The Head of Automation will lead and manage the technical team responsible for delivering automation and system integration projects. This role ensures the successful design, engineering, documentation, and implementation of automation solutions in compliance with industry standards and client requirements. The position requires strong leadership, extensive technical expertise in automation, and effective coordination with internal teams and external stakeholders to achieve project success. A key aspect of the role involves developing and expanding the customer base in collaboration with the Sales Manager. Key Responsibilities Leadership & Management <ul><li>Lead, mentor, and manage a multidisciplinary team of automation, mechatronic, and electrical engineers.</li><li>Ensure company procedures, workflows, and engineering standards are consistently followed for efficiency and quality.</li><li>Monitor team performance and provide opportunities for technical and professional development.</li><li>Identify, pursue, and develop new business opportunities.</li><li>Oversee the recruitment and onboarding of new team members as required.</li></ul>Technical Oversight <ul><li>Review, validate, and approve automation system designs, control system architectures, and PLC/HMI/SCADA programming deliverables.</li><li>Ensure all solutions comply with relevant standards and industry best practices.</li><li>Provide technical guidance and troubleshooting support throughout the project lifecycle.</li></ul>Project Coordination <ul><li>Collaborate with project managers, site teams, and procurement to align technical deliverables with project schedules and budgets.</li><li>Coordinate with clients, consultants, and technology partners to resolve technical challenges and ensure system compatibility.</li><li>Review and validate Bills of Materials (BOMs), hardware/software specifications, and integration strategies.</li><li>Manage and document design changes, revisions, and client-approved modifications.</li></ul>Compliance & Quality <ul><li>Ensure all system designs meet client specifications, safety standards, and regulatory requirements.</li><li>Oversee Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), and provide support during commissioning.</li><li>Implement quality control measures, risk assessments, and cybersecurity considerations in all designs.</li></ul>Reporting & Documentation <ul><li>Maintain accurate and complete project documentation in line with company procedures.</li><li>Provide regular technical progress reports, forecasts, and risk assessments to senior management.</li></ul>

Head of Automation

Senior Mechanical Engineer – Galway Overview A leading provider of materials handling and advanced automation solutions is seeking a highly skilled Senior Mechanical Engineer to drive the design, development, and delivery of innovative mechanical systems within turnkey automation projects. The ideal candidate will bring strong technical expertise, exceptional problem-solving ability, and a commitment to engineering excellence. Key Responsibilities <ul><li>Lead the mechanical design of automated machinery, materials handling equipment, and custom-engineered solutions.</li><li>Produce high-quality 3D models, detailed manufacturing drawings, and technical documentation.</li><li>Perform engineering calculations, tolerance analysis, material selection, and design validation.</li><li>Collaborate with electrical, controls, manufacturing, and project management teams to ensure successful project execution.</li><li>Support concept development, feasibility studies, and cost estimation for new opportunities.</li><li>Provide technical leadership and mentorship to junior engineers and designers.</li><li>Conduct design reviews, risk assessments, and ensure compliance with relevant standards and safety regulations.</li><li>Engage with suppliers and fabrication partners to optimize manufacturability and quality.</li><li>Support equipment installation, commissioning, and troubleshooting when required.</li><li>Drive continuous improvement of engineering processes, tools, and best practices.</li></ul>Required Skills & Experience <ul><li>Bachelor’s degree in Mechanical Engineering (Master’s preferred).</li><li>7 years of mechanical design experience within automation, machinery, materials handling, robotics, or related fields.</li><li>Expert proficiency with CAD software (e.g., SolidWorks, Inventor, or equivalent).</li><li>Strong understanding of mechanical systems, kinematics, pneumatics, hydraulics, and structural design.</li><li>Proven ability to lead design projects from concept through completion.</li><li>Experience with manufacturing processes such as machining, fabrication, and assembly.</li><li>Excellent analytical, problem-solving, and communication skills.</li><li>Ability to manage multiple projects in a fast-paced environment.</li></ul>Desirable Qualifications <ul><li>Experience with automation integration and motion systems.</li><li>Knowledge of FEA, simulation tools, and optimization techniques.</li><li>Familiarity with CE/UL standards and machinery safety regulations.</li><li>Hands-on involvement with on-site installation or commissioning.</li><li>Project management experience or relevant certification.</li></ul>

Senior Mechanical Engineer

Role Overview The successful candidate will be responsible for designing, coding, and testing DeltaV software modifications across all stages of the project lifecycle. This includes working with a range of automation systems such as PLCs, DCS platforms, and related technologies. You will contribute to the development and execution of automation strategies and participate in design reviews, commissioning activities, and validation processes to ensure high-quality project delivery.   Key Responsibilities <ul><li>Design, implement, and test DeltaV software changes in alignment with project requirements.</li><li>Support and integrate additional automation systems including PLCs, DCS platforms, historians, and MES systems.</li><li>Participate in technical strategy development for automated project execution.</li><li>Perform detailed reviews throughout design, commissioning, and validation phases.</li><li>Collaborate with cross-functional teams and stakeholders at various organizational levels.</li><li>Troubleshoot, problem-solve, and support automation systems throughout the project lifecycle.</li><li>Work independently and remotely with minimal supervision while maintaining strong customer relationships.</li></ul>  Required Skills & Experience <ul><li>Significant, hands-on experience with Emerson DeltaV Distributed Control Systems.</li><li>Strong knowledge of batch processing and familiarity with S88 standards.</li><li>Ideally trained through Emerson’s in-house DeltaV training program.</li><li>Minimum of 5 years’ experience in automation systems administration with expertise in one or more of the following:<ul><li>Rockwell FactoryTalk</li><li>DCS platforms</li><li>OSI PI Historian</li><li>Syncade</li><li>Siemens systems</li></ul></li><li>Proven communication, collaboration, and organizational skills.</li><li>Strong critical-thinking and customer-relationship management skills.</li><li>Demonstrated project management and problem-solving capabilities.</li></ul>  Candidate Profile <ul><li>Bachelor’s degree (B.Sc.) in Engineering or equivalent discipline, ideally in software development, electrical, electronic, or automation engineering.</li><li>Minimum 5 years of industry experience, preferably in pharmaceutical, biotechnology, blue-chip, or other GMP-regulated manufacturing environments.</li><li>Excellent communication abilities and strong technical problem-solving skills.</li><li>Candidates with formal Emerson DeltaV training through the dedicated training center will be given preference.</li></ul>  For a confidential conversation about the role please apply for the role or 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.

Delta V Engineer

Senior Quality Engineer Location: Galway, Ireland (Hybrid) Department: Operations Type: Full-time, Permanent Role Overview The Senior Quality Engineer will lead operations quality activities to support the commercialisation and manufacturing scale-up of a new electro-mechanical medical device. The role ensures full compliance with regulatory standards while working closely with a contract manufacturing partner to establish, validate, and maintain robust production and quality processes. Key Responsibilities <ul><li>Ensure compliance with FDA QSR 21 CFR 820, ISO 13485, ISO 14971, EU MDR, and other applicable regulations.</li><li>Lead operations quality engineering for new product introduction, including risk management, verification & validation, process controls, CAPA, documentation, and production ramp.</li><li>Develop and maintain process validation (IQ/OQ/PQ), equipment qualification, and test method validation, in collaboration with contract manufacturers.</li><li>Drive root cause analysis, CAPA, non-conformance investigations, and quality trending.</li><li>Support supplier quality activities including audits, qualification, and performance monitoring.</li><li>Participate in internal/external audits (FDA, NB, ISO, MDSAP).</li><li>Develop quality metrics, support management reviews, and lead continuous improvement initiatives.</li><li>Collaborate with cross-functional teams (R&D, Manufacturing, Supplier Quality, RA/QA) with a strong compliance-focused mindset.</li><li>Create and maintain quality procedures, work instructions, and specifications.</li></ul>Required Qualifications & Skills <ul><li>Bachelor’s degree in Engineering, Life Sciences, or related technical field.</li><li>5–8 years’ experience in medical device quality engineering, including:<ul><li>Electro-mechanical medical devices or similar regulated technology.</li><li>Contract manufacturing (CMO) oversight and supplier quality experience.</li><li>Hands-on design controls, risk management, process validation, production controls, and CAPA.</li></ul></li><li>Strong knowledge of FDA QSR, ISO 13485, ISO 14971, and EU MDR.</li><li>Proficiency in statistical tools (Minitab or equivalent) and quality tools (FMEA, SPC, DOE, RCA).</li><li>Strong analytical, problem-solving, and communication skills with a “quality-first” mindset.</li></ul>

Project Engineer – 12-Month Contract We are seeking a skilled Project Engineer to join a dynamic manufacturing site on a 12-month contract. This hands-on role offers the opportunity to manage capital projects, support process engineering, and drive continuous improvement initiatives in a regulated environment. Key Responsibilities<ul><li>Provide engineering services to maximise availability of process equipment and utilities.</li><li>Manage capital engineering projects (up to €5M) from feasibility to completion.</li><li>Support uptime and efficiency of process equipment, ensuring optimal performance.</li><li>Deliver process engineering support, troubleshooting, and technical solutions for site operations.</li><li>Identify, lead, and implement continuous improvement initiatives.</li><li>Execute engineering projects, including process safety initiatives.</li><li>Collaborate with production, engineering teams, and external contractors for installation, commissioning, and maintenance of equipment.</li><li>Lead commissioning and validation activities for process equipment.</li><li>Prepare feasibility studies, capital proposals, and manage project budgets.</li><li>Support major site initiatives and ensure alignment with operational goals.</li></ul>Essential Requirements<ul><li>Degree in Mechanical, Chemical, or Process Engineering.</li><li>5+ years’ experience in API, OSD, or Biopharma manufacturing (3+ years may be considered with relevant project experience).</li><li>Proven track record delivering capital projects, including new equipment, utilities, or facilities.</li><li>Strong knowledge of change control and C&Q processes.</li><li>Experience with one or more of the following: <ul><li>API process equipment (reactors, filter dryers, pumps, process piping).</li><li>Containment technologies (gloveboxes, downflow booths).</li><li>Drug product equipment (tablet presses, roller compactors, coaters, blenders, Quadro Comils).</li><li>Cleanroom processing/utilities (HVAC, CIP systems, purified water generation/distribution).</li></ul></li><li>Experience in batch processing, automation, commissioning, validation, equipment reliability, and continuous improvement.</li><li>Working knowledge of distributed control systems (e.g., DeltaV).</li><li>Strong problem-solving skills and hands-on approach in a live manufacturing environment.</li><li>Knowledge of cGMP and regulatory requirements in the healthcare industry.</li><li>Proven project management skills, delivering on schedule, within budget, and to quality standards.</li></ul>Desirable<ul><li>Experience with TrackWise change control system.</li><li>Electrical engineering competency, including design and installation of process equipment and site electrical systems.</li><li>Familiarity with ATEX regulations and compliance requirements.</li></ul> For a confidential conversation about the role please apply for the role or 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 - CAPEX

Purpose of the Role To manage and execute engineering projects within the Site Services Group, supporting equipment and process improvement initiatives while ensuring full compliance with site policies across Personnel, Quality, Engineering, Safety and Finance. Key Responsibilities Project & Engineering Management <ul><li>Manage Utilities and Energy–related engineering projects in alignment with the site’s project lifecycle framework.</li><li>Prepare feasibility studies, develop project scopes and manage project budgets.</li><li>Lead negotiation and management of external contractors and service providers.</li><li>Ensure “Right First Time” delivery of all capital projects.</li><li>Prepare and submit Requests for Capital Expenditure (RCE) for plant projects.</li></ul> Operational & Technical Support <ul><li>Provide engineering support to maximise availability and reliability of site process equipment and utilities.</li><li>Support engineering teams in improving equipment uptime and operational efficiency.</li><li>Deliver process engineering expertise, including technical troubleshooting and process optimisation.</li><li>Lead commissioning and validation of process equipment.</li><li>Manage and execute Process Safety projects and support overall site process safety initiatives.</li></ul> Continuous Improvement & Collaboration <ul><li>Identify, lead and deliver continuous improvement initiatives across the site.</li><li>Collaborate with cross-functional teams to drive operational excellence.</li><li>Liaise with internal and external engineering personnel and maintenance providers for troubleshooting, installation, and commissioning.</li><li>Engage with global or corporate engineering platforms and forums where required.</li></ul> Compliance & Safety <ul><li>Ensure adherence to all site safety standards and safe working practices.</li><li>Maintain compliance with cGMP, regulatory requirements and engineering governance.</li><li>Support and comply with change control procedures.</li></ul> Qualifications & Experience <ul><li>Bachelor’s Degree in Engineering or a relevant discipline.</li><li>Minimum 2+ years’ experience as a Project Engineer.</li><li>5+ years’ experience in the pharmaceutical or biopharmaceutical industry.</li><li>Demonstrated ability to deliver projects on schedule, within budget and to required quality standards.</li><li>Knowledge of cGMP and pharmaceutical regulatory requirements.</li><li>Experience in batch processing, automation, commissioning, validation and equipment reliability.</li><li>Working knowledge of distributed control systems (e.g., DeltaV).</li><li>Logical, structured, and hands-on problem-solving approach.</li></ul> For a confidential conversation about the role please apply for the role or 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.

Utilities & Energy Project Engineer

Job Title: Business Systems Analyst  Location:    Mayo  Status:     Permanent Position Summary: <ul><li>The Senior Specialist, Business Systems Analyst is responsible for analyzing, designing, testing, and implementing business processes and the software applications that support them. </li><li>Focused on Manufacturing Finance and Controlling, the role ensures operational efficiency, drives process improvements, and aligns technology with business goals. </li><li>Key functional areas include Cost Center Accounting, Product & Production Costing, Inventory Accounting, Profitability Analysis, and related financial reporting.</li></ul>  Key Responsibilities: <ul><li>Maintain and support critical business processes and system functionality.</li><li>Troubleshoot and resolve production issues following IT standards.</li><li>Develop and update process documentation, functional specs, and process flows.</li><li>Deliver user training and share best practices across teams.</li><li>Lead routine process and system enhancements using SDLC and project management methodologies.</li></ul>  Qualifications and Requirements: <ul><li>8–12 years total work experience, including in business process analysis and design.</li><li>Strong business analysis expertise and knowledge of industry and technology trends.</li><li>Flexibility to work off-hours for projects and travel domestically/internationally.</li><li>Advanced knowledge of SAP ECC 6.0 and S/4HANA 2023</li><li>Bachelor’s degree in Computer Science, Finance, Accounting, Business Systems, or related field</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 Systems Analyst

Our client is seeking a highly skilled Senior Procure to Pay (PTP) Specialist to join their team in Westport. This role acts as a PTP Subject Matter Expert and business partner to site operations, ensuring compliance, efficiency and strong service delivery across all Procure to Pay activities. The ideal candidate will bring proven PTP expertise, strong analytical skills, excellent attention to detail and the confidence to build effective relationships with internal teams, external stakeholders and suppliers. Experience in process development or implementation is an added advantage. Key Responsibilities <ul><li>Ensure full compliance with approved PTP policies, procedures and work instructions.</li><li>Guide internal requestors on appropriate purchasing and buying methods for goods and services.</li><li>Maintain, review, and update departmental training manuals and process documentation.</li><li>Cross-train team members and provide backup support across PTP activities when required.</li><li>Provide day-to-day guidance and support to team members to resolve issues and queries.</li><li>Maintain organised and accurate files and records to support efficient PTP operations.</li><li>Participate in PTP governance meetings and support continuous process improvement.</li><li>Perform workflow administration, including creating substitution rules, delegations and workflow forwarding.</li><li>Raise Administrative Check Requests (ACRs) for non-PO invoice postings as requested by the business.</li><li>Complete monthly reconciliations of GR/IR accounts, open items and down payment reports.</li><li>Respond to business, supplier, finance and shared services queries in a timely and professional manner.</li><li>Collaborate regularly with internal customers and support functions to ensure service satisfaction.</li><li>Investigate and resolve invoice discrepancies for both PO and non-PO purchases.</li><li>Review shopping carts for compliance with purchasing policies.</li><li>Perform Goods Receipt confirmations on behalf of requestors when required.</li><li>Support vendor setup activities and ongoing vendor account maintenance.</li></ul> Qualifications & Experience <ul><li>Bachelor’s degree or a minimum of 5 years' relevant work experience.</li><li>Strong and proven experience in Procure to Pay.</li><li>SAP/SRM experience is highly desirable.</li><li>Demonstrated ability to work effectively with cross-functional teams at all levels.</li><li>Excellent communication, presentation and interpersonal skills.</li><li>Strong organisational skills with the ability to manage multiple tasks and priorities.</li><li>Proficiency in MS Excel, Word, PowerPoint, Outlook and the ability to learn new systems quickly.</li><li>High level of initiative, self-motivation and problem-solving capability.</li></ul> For a confidential conversation about the role please apply for the role or 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.

Senior Procure to Pay (PTP) Specialist

We are seeking a Talent Acquisition Specialist to join a fast-paced, dynamic team and play a key role in attracting top talent across the organization. This position focuses on in-house recruitment, supporting hiring managers, and building strong talent pipelines for current and future hiring needs. Key Responsibilities<ul><li>Lead recruitment efforts for assigned teams/functions, with the flexibility to support additional areas as needed.</li><li>Source, attract, and engage top talent through proactive recruiting strategies.</li><li>Manage full-cycle recruitment, including pre-screening candidates, conducting interviews, and coordinating hiring processes.</li><li>Maintain and manage job requisitions, applicant data, and reporting metrics using recruitment systems.</li><li>Build and maintain strong relationships with hiring managers, serving as a trusted advisor on staffing strategies and talent acquisition best practices.</li><li>Prepare and present competitive offer packages, incorporating market data and internal equity considerations.</li><li>Track and report on recruitment metrics, providing insights on industry trends, talent pools, and market intelligence.</li><li>Ensure compliance with applicable employment laws and internal policies throughout the recruitment process.</li></ul> Qualifications<ul><li>Bachelor’s degree required.</li><li>Minimum of 2 years of recruitment experience in a competitive, fast-paced environment.</li><li>Proven experience with proactive sourcing and talent acquisition strategies.</li><li>Strong professional presence, with the ability to influence stakeholders and deliver measurable results.</li><li>Experience with in-house recruitment and managing requisitions in applicant tracking systems preferred.</li><li>Healthcare or pharmaceutical industry experience is a strong plus.</li></ul>Why Join Us<ul><li>Be part of a collaborative and high-performing team.</li><li>Play a pivotal role in shaping the organization’s talent landscape.</li><li>Opportunities for professional growth and development.</li></ul> For a confidential conversation about the role please apply for the role or 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.

Talent Acquisition Specialist

Single Use Process Scientist Overview We are seeking an experienced Single Use Process Scientist to support new product introductions and process development activities within a GMP biologics/drug product manufacturing environment. This role is responsible for technical execution, process improvement, and ensuring robust and compliant introduction of new products into manufacturing operations. Key Responsibilities NPI & Process Engineering<ul><li>Perform gap analyses, facility fit assessments, process safety reviews, and risk analyses for new product introductions.</li><li>Assist in developing and optimizing manufacturing processes for new products.</li><li>Support process transfers into GMP manufacturing facilities.</li><li>Monitor, trend, and analyze manufacturing process data to ensure process control and performance.</li><li>Lead or support risk assessments such as PFMEA and EHS risk reviews.</li></ul>Technical Support & Documentation<ul><li>Provide operational technical support for process-related issue resolution.</li><li>Prepare, review, and update specifications for NPI-related materials and consumables.</li><li>Develop NPI documentation including transfer plans, protocols, procedures, and batch manufacturing records.</li><li>Lead or support product and process investigations, change controls, and CAPA activities.</li></ul>Cross-Functional Collaboration<ul><li>Work closely with global science, quality, and operations teams to support process development and technology transfer.</li><li>Support, supervise, and train manufacturing personnel on NPI processes and single-use technologies.</li></ul>Compliance<ul><li>Ensure all work complies with GMP, safety, and EHS standards, policies, and procedures.</li></ul>Essential Requirements<ul><li>Bachelor’s degree in Engineering, Science, or a related technical discipline.</li><li>Experience with Single-Use Technologies (e.g., bioreactors, mixers, tubing assemblies); ability to design single-use assemblies for new projects.</li><li>Experience working in a GMP environment with strong documentation and compliance practices.</li><li>Hands-on experience with equipment setup, operation, and troubleshooting of single-use and related process systems.</li><li>Strong communication skills with the ability to collaborate and train cross-functional teams.</li><li>Previous experience in ADC manufacturing.</li><li>Experience with process transfer activities in GMP facilities.</li><li>Knowledge of cleaning study design.</li><li>Experience in upstream processing, UF/DF, mixing, single-use systems, and chromatography.</li><li>Ability to work effectively in teams and influence decision-making.</li></ul>Desired Requirements<ul><li>Master’s degree in a relevant technical discipline.</li><li>3+ years of experience in pharmaceutical or biologics process engineering, including batch processing, scale-up, and technical transfer.</li><li>Experience supporting new product introductions into biologics facilities.</li></ul>Technical & Professional Skills<ul><li>Minimum 1 year in a similar technical operations or process engineering role.</li><li>Minimum 1 year of experience within the pharmaceutical or biotech industry.</li><li>Strong technical understanding of unit operations within a fill-finish or biologics manufacturing facility.</li></ul> For a confidential conversation about the role please apply for the role or 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.

Single Use Process Scientist

DP Process Engineer Department Overview We are seeking an experienced DP Process Engineer to support the introduction, tech transfer, and manufacturing readiness of new drug product (DP) processes within a biologics fill–finish environment. The successful candidate will play a key role in process development, facility fit assessments, risk evaluations, documentation creation, and technical support during GMP manufacturing. This position requires strong technical capability, excellent problem-solving skills, and the ability to collaborate effectively across Operations, Quality, and global scientific teams. Key Responsibilities Process Development & Technical Transfer<ul data-start="969" data-end="1392"><li data-start="969" data-end="1098">Perform gap analyses, facility fit studies, process safety reviews, and risk assessments for New Product Introductions (NPI).</li><li data-start="1099" data-end="1189">Assist in developing and optimizing manufacturing processes for new biologic products.</li><li data-start="1190" data-end="1313">Support technical transfer activities including process assessments, cleaning assessments, and documentation readiness.</li><li data-start="1314" data-end="1392">Monitor and analyze process performance data during manufacturing campaigns.</li></ul>Technical Support & Troubleshooting<ul data-start="1438" data-end="1719"><li data-start="1438" data-end="1524">Provide operational technical support for process deviations and issue resolution.</li><li data-start="1525" data-end="1624">Lead or assist investigations, root-cause analysis, and implementation of process improvements.</li><li data-start="1625" data-end="1719">Prepare, maintain, and update specifications for NPI materials, components, and consumables.</li></ul>Documentation & Risk Management<ul data-start="1761" data-end="1944"><li data-start="1761" data-end="1828">Lead or support PFMEA, EHS, and other process risk assessments.</li><li data-start="1829" data-end="1944">Develop NPI-related documentation such as transfer plans, protocols, procedures, and manufacturing batch records.</li></ul>Collaboration & Training<ul data-start="1979" data-end="2241"><li data-start="1979" data-end="2084">Work closely with cross-functional and global teams throughout process development and NPI execution.</li><li data-start="2085" data-end="2172">Support, train, and supervise operations personnel on new processes and procedures.</li><li data-start="2173" data-end="2241">Ensure adherence to all EHS&E standards, policies, and procedures.</li></ul> Essential Requirements<ul data-start="2278" data-end="2629"><li data-start="2278" data-end="2359">Bachelor’s degree in Engineering, Science, or a related technical discipline.</li><li data-start="2360" data-end="2415">Experience with biologics DP fill–finish processes.</li><li data-start="2416" data-end="2463">Experience with lyophilized (LYO) products.</li><li data-start="2464" data-end="2566">Experience supporting technical transfer activities (e.g., gap assessments, cleaning assessments).</li><li data-start="2567" data-end="2629">Familiarity with single-use system design for DP operations.</li></ul> Desired Requirements<ul data-start="2664" data-end="2947"><li data-start="2664" data-end="2731">Master’s degree in a relevant technical discipline (preferred).</li><li data-start="2732" data-end="2875">Minimum 3 years’ experience in pharmaceutical or biologics process engineering, including scale-up and tech transfer in a cGMP environment.</li><li data-start="2876" data-end="2947">Experience with new product introductions in biologics manufacturing.</li></ul> Additional Skills<ul data-start="2979" data-end="3237"><li data-start="2979" data-end="3072">Minimum 1 year in a similar role within the pharmaceutical or biopharmaceutical industry.</li><li data-start="3073" data-end="3155">Strong technical and operational understanding of fill–finish unit operations.</li><li data-start="3156" data-end="3237">Excellent analytical, communication, and cross-functional collaboration skills.</li></ul> For a confidential conversation about the role please apply for the role or 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.

CP Process Engineer

Robotics Project Engineer Primary Responsibilities: <ul><li>Support the execution of robotics projects at multiple international sites (Germany, Ireland, Italy, France, Singapore), contributing to planning, implementation, and delivery.</li><li>Collaborate with cross-functional site teams to clearly define project scope, objectives, and deliverables that align with both business and technical needs.</li><li>Build and maintain strong relationships with site teams, stakeholders, and vendors to anticipate challenges, resolve roadblocks, and ensure successful project outcomes across a range of environments—including highly regulated sectors like Pharma, biotech, or similar.</li><li>Articulate the value proposition and expected benefits of robotics projects, incorporating productivity, efficiency, safety, and (where relevant) compliance considerations.</li><li>Manage vendor and third-party relationships covering selection, procurement, and ongoing evaluation of products and services, while ensuring vendors can meet specific requirements of regulated industries if applicable.</li><li>Provide hands-on technical leadership to fill capability gaps within project teams, from requirement gathering to solution delivery and troubleshooting.</li><li>Identify and assess opportunities for future robotics projects, leveraging best practices from both industrial and regulated environments to build a long-term project pipeline (e.g., 2027 and beyond).</li><li>Regularly gather input and feedback from each site to guide the organization’s robotics and automation strategy—addressing both operational value and compliance readiness where necessary.</li><li>Lead and oversee small-scale proof-of-concept (PoC) projects, including piloting new technologies and approaches in various settings such as manufacturing, logistics, or laboratory environments.</li><li>Travel as needed, primarily within Europe and occasionally to international sites, with an ability to adapt to diverse regulatory requirements and operational cultures.</li></ul>  Preferred Experience and Skills: <ul><li>Background in robotics engineering, sales engineering, applications engineering, or similar functions, ideally with experience across leading robotics platforms (e.g., Kuka, FANUC, ABB, UR, MiR, Otto, etc.).</li><li>Proven track record of deploying robotics in manufacturing, logistics, or laboratory processes—converting operational needs into effective automated solutions.</li><li>Experience working in regulated industries (such as Pharma, biotechnology, or medical devices) is an advantage, particularly familiarity with Good Manufacturing Practice (GMP), ISO, or FDA requirements, and validation processes (IQ/OQ/PQ).</li><li>Competence in handling project documentation, risk assessments, and compliance documentation when required.</li><li>Strong communication and stakeholder management skills, with the ability to work across technical and non-technical teams worldwide.</li><li>Adaptive and open mindset, comfortable working in multicultural and multidisciplinary teams, and in both regulated and unregulated environments.</li></ul>

Electronics Project Engineer

Software Controls Engineer Shannon Role Overview The Software Controls Engineer will be responsible for delivering high-quality software solutions for bespoke automated assembly machines used in production environments. Working closely with the Mechanical Design, Controls, and Electrical teams, you will develop cost-effective, reliable, and innovative control solutions for advanced automated equipment. As a key member of the project delivery team, you will oversee software development from concept through to commissioning and validation of new machine control systems. Key Responsibilities <ul><li>Design and develop control system software for new automated machinery, including PLC, HMI, Robotics, Motion, and Vision Systems.</li><li>Test, debug, and commission machine control software to ensure reliable performance.</li><li>Provide technical support to the machine build team throughout all project phases — from design and assembly to final commissioning.</li><li>Participate in design reviews with cross-functional stakeholders.</li><li>Create and maintain all technical documentation for new and upgraded equipment.</li><li>Ensure that all project milestones, timelines, and performance targets are achieved.</li></ul>Qualifications & Experience <ul><li>Degree-level qualification (Level 8 or equivalent) in Automation & Robotics or a related software development discipline.</li><li>Proven experience in a similar software or controls engineering role.</li><li>Proficiency in developing software for PLCs, Robots, HMIs, and Vision Systems.</li><li>Experience with robotics, servo-electric, and pneumatic motion control systems.</li><li>Strong understanding of machine safety requirements.</li></ul>Skills & Competencies <ul><li>Excellent problem-solving and troubleshooting abilities.</li><li>Strong time management and task prioritisation skills.</li><li>Ability to work effectively both independently and as part of a multidisciplinary team.</li><li>High attention to detail and commitment to quality.</li><li>Strong verbal and written communication skills.</li></ul>

Software Controls Engineer

Software Controls Engineer We’re seeking an experienced Software Controls Engineer to join a leading manufacturer developing innovative automated assembly solutions. This is an exciting opportunity to work on state-of-the-art automation projects, delivering high-quality software and control systems for bespoke machinery. As a key member of the project delivery team, you’ll take ownership of the software development process — from concept and design through to commissioning and validation — collaborating closely with mechanical, electrical, and controls engineers to bring advanced automation systems to life. Key Responsibilities<ul><li>Design and develop control system software for automated machinery, including PLC, HMI, Robotics, Motion, and Vision Systems.</li><li>Test, debug, and commission machine control software.</li><li>Provide technical support throughout the project lifecycle, including design, machine build, and commissioning phases.</li><li>Participate in design reviews and contribute to continuous improvement initiatives.</li><li>Create and maintain detailed technical documentation for new and upgraded equipment.</li><li>Ensure that all project timelines, performance, and quality targets are achieved.</li></ul> Skills & Experience<ul><li>Degree-level qualification (Level 8 or equivalent) in Automation & Robotics, Software Engineering, or a related discipline.</li><li>Proven experience in a similar Software Controls or Automation Engineering role.</li><li>Proficient in developing software for PLC, HMI, Robotics, and Vision Systems.</li><li>Experience with servo-electric, pneumatic, and robotic motion control systems.</li><li>Solid understanding of machine safety standards and compliance requirements.</li></ul> Key Competencies<ul><li>Strong problem-solving and troubleshooting abilities.</li><li>Excellent attention to detail and commitment to software quality.</li><li>Effective time management with the ability to prioritise tasks.</li><li>Team-oriented mindset with the ability to work independently when required.</li><li>Strong communication and interpersonal skills.</li></ul>

Product Regulatory Engineer We are seeking a highly skilled and proactive Product Regulatory Engineer to lead regulatory compliance efforts across international markets. This role is ideal for a professional with strong technical, analytical, and communication skills who can navigate complex regulatory frameworks and ensure full product compliance from design through post-market activities. Key Responsibilities: Regulatory Strategy & Oversight <ul><li>Develop, implement, and maintain a comprehensive global regulatory compliance strategy aligned with business goals and market expansion.</li><li>Monitor, interpret, and apply national, regional, and international regulations, standards, and directives (e.g., CPR, RED, LVD, EMC, RoHS, WEEE, UKCA, UL, CE, BSI, VdS).</li><li>Provide expert guidance to cross-functional teams (R&D, Quality, Manufacturing, Sales, Marketing) throughout the product lifecycle.</li><li>Identify potential regulatory risks and opportunities, developing mitigation and action plans.</li></ul>Product Approvals & Certification <ul><li>Manage and oversee product approvals and certifications for new and existing products across global markets.</li><li>Prepare and submit technical documentation, test reports, and Declarations of Conformity to certification and regulatory bodies.</li><li>Coordinate internal and external testing to verify compliance with relevant standards.</li><li>Maintain all certifications, licenses, and declarations, ensuring continued validity and accuracy.</li></ul>Regulatory & Notified Body Engagement <ul><li>Act as the primary point of contact for Notified Bodies, certification agencies, and regulatory authorities.</li><li>Manage audits, inspections, and assessments, addressing any findings to ensure timely approvals.</li><li>Build and maintain strong professional relationships with key regulatory stakeholders.</li></ul>Documentation & Quality Systems <ul><li>Establish and maintain comprehensive regulatory documentation and records.</li><li>Collaborate with Quality teams to integrate regulatory requirements into the Quality Management System (e.g., ISO 9001, EN 13980).</li><li>Develop and deliver training on regulatory compliance to internal teams.</li><li>Ensure product labelling, manuals, and marketing materials meet applicable regulations.</li></ul>Post-Market Compliance <ul><li>Support post-market surveillance and incident reviews for regulatory impact.</li><li>Manage product changes to ensure ongoing compliance.</li><li>Coordinate product recall activities if required, in alignment with regulatory expectations.</li></ul> About You Essential Requirements <ul><li>Bachelor’s degree in Engineering, Science, Law, or a related technical field.</li><li>Minimum 3 years’ experience in a dedicated product regulatory role within a manufacturing or regulated environment (preferably electronics or consumer goods).</li><li>In-depth knowledge of major international regulatory frameworks (CPR, RED, LVD, EMC, RoHS, WEEE, REACH, UKCA, UL, BSI, VdS).</li><li>Proven experience managing complex product approval processes and working with Notified Bodies.</li><li>Strong understanding of quality management systems (ISO 9001 or equivalent).</li><li>Excellent written and verbal communication skills with the ability to explain complex regulations clearly.</li><li>Highly organised, detail-oriented, and proactive, with strong project management capabilities.</li></ul> Desirable <ul><li>Master’s degree or higher in a relevant discipline.</li><li>Experience within the fire safety or security industry.</li><li>Knowledge of global market access strategies.</li><li>Legal or regulatory affairs qualification.</li><li>Fluency in additional languages.</li></ul>Key Competencies <ul><li>High integrity and professionalism.</li><li>Strong analytical and problem-solving ability.</li><li>Influential communication and stakeholder management skills.</li><li>Adaptability and resilience in a fast-changing regulatory environment.</li><li>Commitment to continuous learning and professional growth.</li></ul> For a confidential conversation about the role please apply for the role or 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.

Product Regulatory Engineer

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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.

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

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

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

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

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

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

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

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

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

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

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<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>

<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.

About Aidan
Aidan McNabola is a seasoned engineering professional with over 38 years of leadership experience in engineering and manufacturing, including 16 years specifically in sterile manufacturing across five sites. They have managed both direct and indirect teams of over 50 people and have extensive experience in corporate governance, including remediation, regulatory compliance, and inspections. Their background also includes leading greenfield operations from startup through acquisition and overseeing projects ranging from &euro;50,000 to &euro;150 million.
&nbsp;
Career Highlights:
<ul>
<li>
Viatris Pharmaceuticals &ndash; Senior Director of Engineering. (6 years) Managed engineering activities for the Sterile filling operations. Managed the conceptual and detailed design and install of a sterile cartridge filling and assembly line . Capex value 30mill. Euros.
</li>
<li>
Taro Pharma &ndash; Engineering Manager. Managed site engineering activities for a sterile fill finish facility. Conceptual and detailed design for two new Aseptic Fill Finish Lines.
</li>
<li>
Elan Pharma &ndash; Senior Project Manager. Front end study and detailed design for a new Fill Finish facility.
</li>
<li>
Allergan Pharmaceuticals &ndash; Engineering Manager. Design, Build, start up of a new Botox facility 20Mill.
</li>
<li>
GE Healthcare &ndash; Senior Project Manager/Operations. Managed sterile filling operations. Installation of a new sterile bottle filling line and start up operations.
</li>
</ul>
&nbsp;
Education &amp; Qualifications:&nbsp;
<ul>
<li>Degree Mechanical Engineering, University Limerick</li>
<li>Chartered Eng. FIEI.</li>
<li>PMP Certified</li>
<li>Green Belt Certified</li>
<li>Level 6 Coaching Cert.</li>
</ul>

Aidan McNabola

About Todd
With over 25 years of engineering and manufacturing leadership, Todd Johnson has consistently delivered operational excellence across complex, large-scale environments. He has provided direct and indirect oversight of teams exceeding 3,000 employees and has managed multi-plant operations with a focus on efficiency, compliance, and strategic growth. His expertise spans corporate governance, including remediation efforts, regulatory compliance, and successful navigation of inspections. Todd has led greenfield operations from initial startup through acquisition and has overseen capital projects ranging from $75,000 to $750 million, demonstrating a strong track record in project execution and organizational transformation.
Todd&rsquo;s leadership has been instrumental in several high-impact roles throughout his career. As VP of Engineering and Operations at Point BioPharma, he led the startup of manufacturing operations, including technology transfer, product development, and compliance with government regulatory requirements. His specialized expertise in radioligand therapies played a key role in the successful transition of business and operations to Eli Lilly. Todd also managed investor and client expectations, ensuring project delivery and securing necessary funding. At Zimmer Biomet, he served as Director of Engineering and Operations, overseeing highly customized medical device manufacturing. He implemented inventory controls, enhanced quality record management, and led a full overhaul of the quality systems. As Director of Engineering and Operations at Pharmedium, Todd focused on multi-site process standardization, led cleanroom expansions for continuous line operations, and optimized cycle times in batch manufacturing environments. At Baxter, he held the role of Senior Director of Engineering and Operations, where he drove continuous improvement initiatives to enhance OEE, managed large-scale CAPEX projects, led S&amp;OP processes, and oversaw new product introductions. He also played a pivotal role in the acquisition and integration of an aseptic filling/API facility in India. Early in his career at Abbott Laboratories, Todd served as Maintenance Manager, where he was deeply involved in navigating a consent decree and implementing corrective and preventive actions (CAPA), DMAIC, Six Sigma, and Lean methodologies to support long-term compliance and performance improvement.
Todd holds a Bachelor of Science in Electrical Systems from Southern Illinois University and is a certified Six Sigma Green Belt.

Todd Johnson

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.

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