Engineering Compliance Specialist

Engineering Compliance Specialist

This is your opportunity to join a highly regulated GMP and sterile manufacturing environment in Carlow, Co. Carlow , supporting Engineering operations and helping maintain a strong culture of compliance, quality and inspection readiness .

You'll work across deviations, root cause investigations, CAPAs, change controls, GMP documentation and audit readiness , collaborating with Engineering, Quality, EHS, IPT and Technical Engineering teams to support safe, compliant and effective operations.

If you're an experienced Engineering, Quality or Manufacturing Compliance professional with previous experience in a GMP manufacturing environment , this role offers the opportunity to develop your expertise across Engineering compliance, regulatory requirements and inspection readiness.

• Lead and/or support deviations, out of tolerance conditions and unexpected results .
• Conduct failure analysis and root cause investigations .
• Determine and implement effective corrective and preventative actions (CAPAs) .
• Lead and support Engineering change controls .
• Generate, review and expedite GMP documentation .
• Review Engineering documentation, including electronic logs .
• Author, edit and review controlled documents, reports, standards and policies .
• Support audit and inspection readiness activities.
• Work cross functionally with Engineering, Quality, EHS, IPT and Technical Engineering .
• Ensure activities comply with cGMP, regulatory requirements, policies and procedures .
• Support a safe, compliant and inspection ready Engineering environment.

You'll ideally bring:

• A Diploma or higher qualification , preferably in a relevant discipline.
• Previous experience within a GMP manufacturing environment .
• Experience in Engineering, Quality or Manufacturing Compliance .
• Experience with deviations, investigations, root cause analysis and CAPAs .
• Experience with change controls and GMP documentation .
• A strong understanding of regulatory, code and standards requirements .
• Strong report writing, documentation and policy writing skills .
• Excellent analytical and problem solving abilities.
• Strong organisational skills and attention to detail.
• Excellent communication skills and the ability to work across different functions and levels.
• Good proficiency in Microsoft Office and relevant computer applications .

Experience within pharmaceutical or medical device manufacturing , sterile filling processes and equipment , Lean Six Sigma or SOX compliance would be advantageous.

If you're an experienced Engineering Compliance, Quality or GMP professional looking for your next challenge within a highly regulated manufacturing environment, we'd love to hear from you.

All applications are treated in the strictest confidence.