Sterility Assursance Consultant

Walker Cole International is supporting a life sciences organisation in the appointment of a Sterility Assurance and Contamination Control Strategy Consultant. This role will lead the development of a robust Contamination Control Strategy (CCS) framework from the ground up, alongside driving sterility assurance and environmental monitoring practices across the site.

This position will play a critical role in establishing a structured, compliant approach to contamination control, ensuring the facility's aseptic and sterility assurance practices meet regulatory expectations. The successful candidate will bring hands-on sterility assurance expertise, hold responsibility for building the CCS framework rather than refining an existing one, and support the wider team through training and knowledge transfer.

Key Responsibilities

• Build and write the Contamination Control Strategy (CCS) framework from scratch, establishing the structure and approach rather than amending an existing one
• Conduct FMEA and CCS-driven risk assessments across facility, process, people and product flows
• Develop an Environmental Monitoring (EM) programme covering both validation and ongoing routine monitoring
• Provide hands-on sterility assurance input and oversight across aseptic manufacturing/compounding operations
• Lead and support validation activities relevant to sterility assurance
• Deliver training to staff to build internal capability and ensure ongoing adherence to the CCS
• Collaborate with production, quality and operational teams to ensure the CCS reflects real facility operations
• Ensure the CCS is written as a practical, maintainable, living document that the client can own and update going forward

Required Experience and Skills

• Proven experience building and writing a CCS framework from the ground up, not solely maintaining or updating existing documentation
• Experience within an aseptic manufacturing or compounding environment
• Validation experience specific to sterility assurance
• Essential: FMEA and CCS experience
• Hands-on sterility assurance expertise
• Experience developing and implementing EM monitoring programmes, covering both validation and ongoing monitoring
• Demonstrable experience training and upskilling staff
• Strong pragmatic, business-aware approach with the ability to balance regulatory expectations against operational reality
• Excellent communication skills, with the ability to engage confidently across quality, operations and production teams

Working Pattern
On-site, UK

Contract Length
6 months

Rate
Day rate negotiable depending on experience

Location
UK

Keywords
Contamination Control Strategy | CCS | Sterility Assurance | FMEA | Environmental Monitoring | Aseptic Manufacturing | Compounding | Validation | Pharma | Biotech | Contract

Job ID
119657

Contract Information
Email: fk@walkercole.com