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This is a senior, high-impact role for a contamination control leader who combines deep technical expertise with strong on-the-floor influence, embedding contamination control into systems, behaviours, and decision-making across a multi-facility, multi-client manufacturing environment. You will lead, develop and continuously enhance an established, integrated Contamination Control Strategy (CCS), ensuring it remains dynamic, risk-based and aligned with evolving business needs, regulatory expectations, and future-state technologies. Working closely with Manufacturing, MSAT and Quality, you will proactively identify, reduce and eliminate contamination risks across facilities, client products and processes, while maintaining inspection readiness and client confidence.
Job Responsibility:
Own and evolve the site Contamination Control Strategy in line with EU/UK GMP Annex 1, FDA and ICH expectations
Embed contamination control principles into facility and equipment design, process flows, cleaning and sterilisation strategies, supplier management and training programmes
Partner with Manufacturing to influence aseptic behaviours, shift routines, operator decision-making and capability development
Collaborate with MSAT across equipment design, tech transfer, scale-up, process characterisation and new product introduction
Ensure full integration of the CCS with Quality systems including deviations, investigations, CAPAs, change control and audit readiness
Lead contamination-focused risk assessments (including FMEA) across client processes, shared equipment, utilities, campaign manufacturing and changeovers
Translate risk into practical, executable operational controls and maintain assessments as living tools informed by data and trends
Design and deploy contamination control training tailored to a CDMO environment, reinforcing learning through hands-on coaching and on-the-floor engagement
Champion a strong site-wide contamination control culture where prevention is everyone's responsibility
Provide governance-level oversight of contamination-related data, driving continuous improvement and reduction of repeat deviations
Act as the contamination control SME during client audits and regulatory inspections
Requirements:
Degree in Microbiology, Biology, Biochemistry, Chemical Engineering or related discipline (Master's preferred)
Extensive industry experience in sterile or biologics pharmaceutical manufacturing, ideally within a CDMO
Strong expertise in aseptic processing, cleanroom operations and microbiological contamination control
Proven experience leading FMEA and cross-functional risk assessments
Solid understanding of global regulatory expectations
Ability to influence in matrixed environments with strong communication, coaching and facilitation skills
Nice to have:
Hands-on involvement with EU GMP Annex 1 implementation
Experience supporting tech transfer into commercial manufacturing
Regulatory inspection and client audit readiness experience
Background in facilities operating shared equipment or campaign manufacturing
What we offer:
Excellent salary and benefits package including enhanced pension, healthcare and annual bonus scheme
A chance to make a real difference and lead from the front in a key role on site
Working at the forefront of the biologics industry