Sterility & Microbiology Lead – Aseptic Quality (On‑Site)

Ipsen; United Kingdom; Remote; GBP 65,000 - 90,000; Full time

Job summary

Ipsen Biopharm Ltd in the UK is seeking an experienced Sterility Assurance Expert to safeguard aseptically manufactured medicines. You will lead contamination control, oversee environmental monitoring and drive regulatory compliance across global expectations.

Within Technical Operations, you will mentor teams, design risk assessments, and author GMP documentation while supporting inspections and audits to ensure product quality and patient safety.

Qualifications

• Degree in Microbiology or related life sciences.
• Significant experience in aseptic/sterile pharmaceutical manufacturing.
• Strong hands‑on knowledge of sterility assurance and contamination control.
• Experience leading microbiological investigations and risk assessments.

Responsibilities

• Lead sterility assurance and contamination control activities across aseptic manufacturing operations.
• Develop and maintain the site Contamination Control Strategy per EU GMP Annex 1 and regulatory expectations.
• Perform and lead risk assessments related to aseptic processing and cleanroom operations.
• Design and oversee environmental monitoring programmes, trend analysis and investigation of excursions.
• Lead investigations into sterility failures and contamination events, implementing CAPAs.
• Provide microbiological expertise for cleanroom qualification and aseptic process simulations (media fills).
• Support process validation and continuous improvement across manufacturing operations.
• Collaborate with QA, Manufacturing, Engineering and Validation to embed sterility principles.

Skills

Sterility assurance

Contamination control

Environmental monitoring

Risk assessment

GMP compliance

Technical writing

Education

Degree in Microbiology

Tools

Media fills

Sterilisation validation

Job description

Ipsen Biopharm Ltd in the UK is seeking an experienced Sterility Assurance Expert to safeguard aseptically manufactured medicines. You will lead contamination control, oversee environmental monitoring and drive regulatory compliance across global expectations.

Within Technical Operations, you will mentor teams, design risk assessments, and author GMP documentation while supporting inspections and audits to ensure product quality and patient safety.