GMP Engineering Compliance Lead (Sterile Manufacturing)

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

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.