Sterility Assurance Expert

Overview

In this role you will lead sterility assurance across aseptic manufacturing, shaping site strategy and ensuring regulatory compliance. You will act as SME across contamination control, microbiological risk management, and regulatory readiness, collaborating with QA, Manufacturing, Engineering and Validation. You will lead investigations into sterility failures, drive root cause analysis and CAPAs, and support regulatory inspections. This role offers impact on product quality and patient safety within Ipsen's Quality/Technical Operations.

Responsibilities

• Lead sterility assurance and contamination control activities across aseptic manufacturing operations
• Develop and maintain the site's Contamination Control Strategy in line with EU GMP Annex 1 and international regulatory expectations
• Perform and lead risk assessments related to aseptic processing, cleanroom operations, isolator systems and critical interventions
• Design and oversee environmental monitoring programmes, including trend analysis and investigation of excursions
• Lead investigations into sterility failures, bioburden excursions, environmental monitoring out-of-specification results and contamination events
• Drive root cause analysis and implementation of CAPAs
• Provide microbiological expertise for cleanroom qualification, sterilisation processes, filtration systems, disinfectant qualification and aseptic process simulations (media fills)
• Support process validation and continuous improvement initiatives across manufacturing operations
• Collaborate with Quality Assurance, Manufacturing, Engineering and Validation to embed sterility principles into processes and facility design
• Author, review and approve GMP documentation (SOPs, protocols, reports, technical assessments)
• Support regulatory inspections and customer audits as the site expert for sterility assurance
• Coach, mentor and develop colleagues in aseptic technique and microbiological best practice

Key requirements

• Degree in Microbiology, Life Sciences or a related scientific discipline
• Significant experience within aseptic or sterile pharmaceutical manufacturing
• Strong hands-on knowledge of sterility assurance and contamination control principles
• Experience leading microbiological investigations and risk assessments
• Understanding of GMP regulations and industry standards (EU GMP, Annex 1, FDA and PIC/S)
• Experience interpreting microbiological, environmental monitoring and trend data
• Excellent technical writing, communication and stakeholder management skills
• Ability to influence cross-functional teams and drive quality-focused decision making

• technical writing
• stakeholder management
• influence across cross-functional teams
• sterility assurance
• contamination control
• environmental monitoring

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