Sterility Assurance Lead — 12‑Month Contract

CSL Plasma Inc.; Liverpool; On-site; GBP 50,000 - GBP 70,000; Full time

Job summary

A leading biopharmaceutical company in Liverpool is searching for a Sterility Assurance Manager for a 12-month fixed term contract. The role involves ensuring compliance with Good Manufacturing Practices, leading change management processes, and supporting the manufacturing operations from a sterility assurance perspective. Candidates should have over 5 years' experience in a GMP environment, a degree in Microbiology or related field, and strong knowledge of aseptic processes. A collaborative approach to coaching and training manufacturing staff is essential.

Qualifications

• 5+ years' GMP experience in pharmaceutical/biotech/regulated industry.
• Experience in Aseptic Manufacturing/Oversight or Sterility Assurance/Quality role.
• Ability to author product impact assessments.

Responsibilities

• Provide sterility assurance support for manufacturing operations.
• Lead change management processes and investigations.
• Advocate for training programs and maintain knowledge of regulatory updates.

Skills

GMP experience

Aseptic Manufacturing

Risk Based Decision making

Quality Risk Management

Education

Bachelor's degree in Microbiology or related field

Advanced degree (Masters/Ph.D)

Job description

A leading biopharmaceutical company in Liverpool is searching for a Sterility Assurance Manager for a 12-month fixed term contract. The role involves ensuring compliance with Good Manufacturing Practices, leading change management processes, and supporting the manufacturing operations from a sterility assurance perspective. Candidates should have over 5 years' experience in a GMP environment, a degree in Microbiology or related field, and strong knowledge of aseptic processes. A collaborative approach to coaching and training manufacturing staff is essential.