Contamination Control Manager

• 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

• 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

• 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

Excellent salary and benefits package including enhanced pension, healthcare and annual bonus scheme