Sterility Assurance Officer

Sterility Assurance Officer

We’re supporting a leading pharmaceutical manufacturing site to hire a Sterility Assurance Officer – a highly visible role sitting at the heart of aseptic operations, quality, and compliance.

This is an opportunity to step into a role where you’re not just maintaining standards, you’re actively shaping sterility assurance strategy, influencing behaviours on the shop floor, and driving continuous improvement across a complex GMP environment.

The Role

You’ll act as a subject matter expert for sterility assurance, working closely with manufacturing, production, engineering and QA teams to ensure the highest standards of aseptic performance across site.

This is a hands-on, site-facing position where you’ll coach teams, challenge practices, and lead investigations, playing a key role in maintaining compliance and improving operational quality.

Key Responsibilities

· Support sterile and IMP manufacturing activities from a sterility assurance perspective

· Champion and embed best-in-class aseptic behaviours across operational teams

· Deliver training and coaching to improve understanding of aseptic practices

· Lead and support non-conformance, complaint and OOX investigations (including GEMBA and report writing)

· Drive CAPA activities, change controls, and quality risk management initiatives

· Contribute to and enhance the site’s sterility assurance programme

· Analyse and present environmental monitoring trends to key stakeholders

· Provide sterility assurance input into shutdowns, new equipment and validation activities

· Partner with teams across site to influence standards and drive continuous improvement

What We’re Looking For

· Proven experience within a sterile GMP manufacturing environment

· Experience leading investigations, CAPA and root cause analysis

· Solid understanding of GxP regulations and aseptic processing standards

· Ability to train, influence and challenge operational teams on behaviours and compliance

· Degree (or equivalent) in a relevant scientific discipline

· Track record of driving quality or compliance improvement initiatives

Why This Role?

· High-impact position with real visibility across manufacturing and quality

· Opportunity to drive behavioural change and influence site culture

· Exposure to complex sterile manufacturing operations and ongoing improvement projects

· Strong leadership reporting line into the Sterility Assurance Manager

Working Pattern

This is a site-based, rotating shift role:

· Week 1: 06:00 – 14:00

· Week 2: 10:00 – 18:00

· Week 3: 14:00 – 22:00