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.Company OverviewLeading pharmaceutical manufacturing siteResponsibilities/Role
- 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
Experience & QualificationsProven 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
Benefits
- 15% Shift allowance
- High-impact position with real visibility across manufacturing and quality
- Exposure to complex sterile manufacturing operations and ongoing improvement projects
- Strong leadership reporting line into the Sterility Assurance Manager
Site-based, rotating shift role:
- Week 1: 06:00 – 14:00
- Week 2: 10:00 – 18:00
- Week 3: 14:00 – 22:00
Office based (Site-based / Shift work)