Senior Process Validation Manager

About the role

We are seeking a senior leader to drive validation strategy and excellence across a global healthcare manufacturing network. The role will oversee equipment, facilities, utilities, automated systems, process and cleaning validation, ensuring compliance with GMP and industry regulations.

Key responsibilities

• Lead a globally dispersed Validation Engineering team, defining strategy, planning and execution across multiple sites.
• Develop and implement validation strategies aligned with global technical operations.
• Oversee validation activities for equipment, facilities, utilities, automated systems, processes and cleaning validation.
• Approve and review Validation Master Plans, protocols and documentation (IQ, OQ, PQ, FAT, SAT).
• Drive standardisation and harmonisation of validation processes across global sites.
• Champion risk‑based and science‑driven validation approaches.
• Ensure ongoing compliance through periodic reviews and governance of validated systems.
• Support technology transfers, new product introductions and process implementation.
• Partner with Quality, Engineering, Manufacturing and other cross‑functional teams.
• Lead, coach and develop a high‑performing validation team.
• Support continuous improvement and Lean Sigma initiatives.

Required profile

• Degree in Engineering, Computer Science or a related discipline.
• 10+ years validation engineering experience in a cGMP environment.
• 10+ years experience in high‑volume pharma or medical device manufacturing.
• Proven people‑management experience.
• Strong knowledge of EU GMP, ISO 13485 and FDA CFR Part 820.
• Experience across IQ, OQ, PQ and the full validation lifecycle.
• Strong communication and stakeholder‑management skills.
• Ability to work in a matrix, multi‑site environment.
• Willingness to travel (~5%).

Required skills

• cGMP
• EU GMP
• ISO 13485
• FDA CFR Part 820
• IQ, OQ, PQ
• FAT, SAT
• Validation Master Plan development
• Risk‑based validation
• CSV (Computer System Validation)
• Lean
• Continuous Improvement
• Electronic validation systems