Engineering Compliance Specialist

Next Generation; Carlow; On-site; EUR 60,000 - 90,000; Full time

Job summary

Next Generation in Carlow is seeking an Engineering Compliance Specialist to join a GMP manufacturing environment. You will support engineering operations and help sustain a culture of compliance, quality and inspection readiness.

You’ll work across deviations, root-cause investigations, CAPAs, change controls and GMP documentation, collaborating with Engineering, Quality, EHS, IPT and Technical Engineering to ensure safe, compliant and effective operations.

Qualifications

• Diploma or higher qualification in a relevant discipline.
• Experience in a GMP manufacturing environment.
• Experience with deviations, investigations, root-cause analysis and CAPAs.
• Experience with change controls and GMP documentation.
• Strong understanding of regulatory, code and standards requirements.
• Strong report writing and documentation skills.
• Excellent analytical and problem-solving abilities.
• Attention to detail and thorough communication across functions.
• Proficiency in Microsoft Office or similar tools.

Responsibilities

• Lead and/or support deviations, out-of-tolerance conditions and unexpected results.
• Conduct failure analysis and root-cause investigations.
• Determine and implement corrective and preventive 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.

Skills

Deviations handling

Root-cause investigations

CAPAs

Change controls

GMP documentation

Audit readiness

Cross-functional collaboration

Analytical thinking

Communication skills

Attention to detail

Education

Diploma or higher qualification

Tools

Microsoft Office

Job description

Take Your Engineering Compliance Career to the Next Level in Regulated Manufacturing

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.

What you’ll be working on

• 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.

What will make you stand out

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.

Ready for your next move?

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.