Position Summary:
We're looking for an experienced sterility assurance professional to play a central role in strengthening aseptic and contamination control strategy across two sterile manufacturing facilities.
This position sits at the heart of sterile operations partnering with Manufacturing, Engineering and Quality to drive high standards in GMP compliance, aseptic behaviour and contamination control, including support for IMP manufacture.
This is not a purely oversight role it is an operationally embedded position with real influence across production areas.
Key Responsibilities:
Act as the site subject matter expert for sterility assurance and aseptic behaviours
Support sterile manufacturing operations in maintaining and improving GMP compliance
Drive contamination control standards across cleanroom environments
Lead and support investigations (non-conformances, OOX, complaints), including structured root cause analysis and GEMBA activities
Review and trend environmental monitoring data, presenting findings to operational forums
Contribute to contamination control strategy, risk assessments and quality risk management activities
Support validation, equipment introduction and shutdown activities from a sterility assurance perspective
Partner with Engineering and Production to proactively identify and mitigate sterility risks
Support internal audits and inspection readiness activities
Champion continuous improvement across sterile operations
Requirements:
3+ years' experience within pharmaceutical manufacturing, testing or QA
2+ years within a sterile or aseptic manufacturing environment
Strong working knowledge of GMP/GxP and sterile manufacturing principles
Experience supporting investigations and CAPA implementation
Understanding of contamination control strategies and sterility assurance systems
Confident communicator with the ability to influence production and engineering stakeholders
Strong report writing and data analysis capability