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 Ensure new products transferred to the site are manufactured in compliance with applicable regulatory requirements, internal policies, and quality standards. Maintain the effectiveness of quality system integration for all new product introductions. Support new product transfers from development through commercialization, working closely with internal and external cross-functional teams to identify and mitigate quality risks. Provide quality direction and subject matter expertise throughout technology and product transfer activities. Support vendor evaluation and approval processes, including the initiation, review, approval, and maintenance of technical agreements. Review and approve NPI-related analytical test method transfers and/or validation activities. Coordinate site review of new product-related material specifications, including raw materials, excipients, in-process, BDS, and drug product specifications. Support the management of new product-related exceptions, including the development of corrective and preventative actions (CAPAs). Generate and maintain product transfer documentation to support stage gate reviews and commercialization readiness. Act as the quality subject matter expert during internal audits and external regulatory inspections related to new products and technology transfers. Collaborate closely with QA, CMC, R&D, Science & Technology, and other functional groups to ensure clarity of roles, responsibilities, and compliance expectations. Adhere to and actively support all EHS and environmental standards, procedures, and policies. Requirements Third-level qualification in Science, Quality, Engineering, or a related discipline. Minimum of 3 years experience in a quality role supporting New Product Introduction (NPI) within a regulated pharmaceutical or biologics environment. Strong working knowledge of regulatory requirements (GMP, quality systems, and compliance expectations). Experience supporting product or technology transfers from development through commercialization. Excellent cross-functional communication and stakeholder management skills. Desirable Experience working in an aseptic manufacturing or biologics environment. Prior quality experience supporting analytical method transfer and validation activities. For a confidential conversation about the role please apply for the role or contact Owen Clancy at By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose.
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 Lead a multi-functional team to plan, manage, and execute production schedules across the site Manage human and material resources to consistently meet production targets Provide accurate estimated production dates to Quality and other stakeholders to support scheduling activities Liaise closely with Engineering and Purchasing regarding Engineering Change Notices (ECNs), advising on part revisions and ordered components Review, adjust, and communicate production schedules as business needs change Prioritise and expedite urgent or short-lead-time requirements outside standard planning cycles Ensure full traceability of parts throughout the production process Ensure Standard Operating Procedures (SOPs) are adhered to at all times Monitor Health & Safety compliance, recommending and implementing improvements where agreed Capture and analyse capacity data across the product range to continuously improve the planning process Conduct regular performance review meetings with Supervisor teams to track targets, issues, and improvements Prepare, maintain, and present weekly production performance reports to management Support and participate in organisational structure development to meet evolving site demands Delegate tasks effectively in line with the organisational structure Performance manage, coach, develop, and motivate team members Drive a consistent systems-based and continuous improvement mindset across the organisation Improve product flow through the site using Lean Manufacturing principles Travel nationally and internationally as required Education & Experience Degree in a relevant discipline such as Engineering, Manufacturing, or Science Minimum of 5 years experience in a similar production planning or manufacturing leadership role Experience working within an ISO-certified environment (aviation or regulated industry experience is advantageous but not essential) Strong understanding and practical experience implementing Lean Manufacturing techniques Experience working with ERP / MRP systems Excellent project management and organisational skills For a confidential conversation about the role please apply for the role or contact Owen Clancy at By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose.
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: Regulatory Compliance: Ensure adherence to medical device regulations (ISO 13485, FDA, MDR) in manufacturing processes. Validation: Lead and execute validation activities (IQ/OQ/PQ) for equipment, processes, and systems. Change Control: Oversee and support change control processes, ensuring proper documentation and approval. Project Execution: Assist in managing project tasks, timelines, and deliverables, working with cross-functional teams. Documentation: Maintain clear documentation for validation, change control, and project progress. Required Skills and Experience: 3+ years of experience in medical device manufacturing, including regulatory compliance and validation. Strong knowledge of FDA, ISO 13485, and EU MDR regulations. Experience in change control processes and project task execution. Excellent attention to detail, communication, and problem-solving skills. Ability to work in a cross-functional team and manage multiple priorities. Contract Duration: 12 months, with potential for extension. Application Process: Please submit your CV and cover letter outlining relevant experience.
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: Evaluate production performance on a daily basis, including labour efficiency and waste metrics, ensuring data integrity and following up on variances. Partner closely with operations teams to provide financial insight and support delivery of performance targets. Analyse financial data and trends to identify process improvements and cost efficiencies. Prepare and present reports to help operations manage labour, material, and overhead costs. Support month-end reporting, providing accurate analysis of material, labour, and overhead variances versus plan. Maintain strong inventory controls. Assist with the preparation of the Annual Operating Plan (AOP) and quarterly forecast reviews. Participate in continuous improvement initiatives, representing finance at tier meetings and problem-solving sessions. Collaborate with operations to ensure integrity of MRP systems, bills of materials, inventory valuation, and subcontracting setups. Support cost improvement projects by evaluating financial impact, forecasting savings, and tracking results. Maintain and update standard costs to ensure accuracy and timeliness. Review monthly volume forecasts and assess labour requirements to support production demand. Perform ad-hoc financial modelling, cost comparisons, and analytical projects as required. Ensure compliance with internal policies and external accounting standards. Experience & Qualifications: 25 years experience in a manufacturing finance environment. Hands-on experience with standard costing is essential. Bachelors degree or diploma in Finance, Accounting, Economics, or a related discipline. Professional accounting qualification (CIMA / ACCA / ACA or equivalent) is desirable but not essential. Skills & Technical Requirements: Advanced Microsoft Excel skills. Experience with ERP systems Power BI or similar reporting tools are desirable. Strong analytical, communication, and presentation skills. For a confidential conversation about the role please apply for the role or contact Owen Clancy at By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose.
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 Lead one or more strategically critical, enterprise-level programs from concept through delivery Translate strategic goals into integrated, portfolio-aligned program plans Orchestrate cross-functional teams across Engineering, Operations, Quality, Regulatory, Clinical, and Marketing Manage interdependencies, risks, resources, and timelines to ensure predictable execution Provide clear, data-driven insights to support senior decision-making Communicate program status, risks, and trade-offs with clarity and authority Coach teams and contribute to continuous improvement of program management standards What Success Looks Like Delivers consistent outcomes in complex, regulated environments Anticipates risks and drives proactive decision-making Influences effectively across functions and leadership levels Balances strategic thinking with operational discipline Requirements 810+ years experience in senior program or core team leadership roles Proven success delivering complex product development programs in regulated environments (medical devices preferred) Strong systems thinking, risk management, and stakeholder influencing skills Experience with Stage-Gate and Project Portfolio Management (PPM) Excellent communication and executive-level reporting capability PMP or equivalent certification preferred Bachelors degree in a technical discipline (advanced degree advantageous) Ability to travel up to 10% Experience working in a hybrid environment
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 Lead and own the development of new and improved manufacturing methods for catheter-based devices Serve as a technical expert in catheter manufacturing processes, materials, and prototyping techniques Rapidly prototype device and fixture concepts in-house using standard catheter manufacturing equipment and 3D printing technologies Perform mechanical modeling and analysis using SolidWorks or equivalent CAD tools Design, develop, and optimize robust manufacturing processes suitable for scale-up and commercialization Design fixtures and test models for proof-of-concept, verification, and validation activities Lead the design, build, and documentation of novel neurovascular catheter technologies Drive and support verification and validation efforts for new product designs and manufacturing processes Develop and manage project plans, technical specifications, timelines, and deliverables Identify, evaluate, and manage external vendors for materials, processes, and manufacturing equipment Contribute to and support the generation of intellectual property, including invention disclosures and patent filings Provide technical guidance and mentorship to junior engineers and cross-functional team members Required Qualifications Bachelors degree in Engineering or a related discipline Minimum of 5+ years experience in the medical device industry, ideally with catheter-based technologies Demonstrated hands-on mindset with a strong track record of practical problem solving Proven ability to rapidly prototype device and fixture concepts using catheter manufacturing techniques and 3D printing Advanced proficiency in mechanical modeling and analysis using SolidWorks or similar CAD tools Strong experience working with medical-grade polymers and materials Deep understanding of manufacturing process development, verification, validation, and implementation Excellent verbal and written communication skills, with the ability to engage effectively across technical and non-technical teams Experience working in dynamic, fast-paced development environments Commitment to continuous professional development and staying current with catheter design, materials, and prototyping techniques
Job Title: CNC Programmer Location: Limerick Status: Permanent Position Summary: The role of CNC Programmer involves programming, setting up, and operating CNC and Swiss-type sliding head machines. 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 Key Responsibilities: Collaborate on process development for new and complex components, working closely with engineering teams. Optimise CNC programs and processes to achieve production efficiency while maintaining the highest quality standards Take ownership of projects, ensuring production goals are met and maintaining strong client satisfaction. Qualifications and Requirements: Experience in programming machines essential 5 years experience in a similar CNC Operator type role. Experience in 5 axis programming andmillturn programming For a confidential conversation about the role contact Karl on or By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose
