Full job descriptionSterility Assurance Specialist


Walker Cole International is partnering with a leading pharmaceutical manufacturer to appoint a Sterility Assurance Specialist. This role will provide technical expertise across sterility assurance, environmental monitoring and microbiology, supporting aseptic manufacturing operations whilst ensuring compliance with GMP requirements.


Key Responsibilities for a Sterility Assurance Specialist:
*Maintaining sterility assurance and environmental monitoring programmes in compliance with current GMP requirements.
*Leading investigations into microbiological deviations, non-conformances, quality incidents and customer complaints, ensuring effective root cause analysis and corrective actions.
*Providing technical expertise on contamination control, microbiological data interpretation and environmental monitoring trending.
*Supporting validation activities, microbiological method development and oversight of external microbiology laboratories.
*Delivering microbiology and aseptic training whilst driving continuous improvement initiatives across manufacturing operations.


A Sterility Assurance Specialist will have:
*A degree in Microbiology or a related scientific discipline, or equivalent industry experience.
*Experience working within a sterile or aseptic pharmaceutical manufacturing environment.
*Strong knowledge of environmental monitoring, contamination control and sterility assurance principles.
*Experience investigating microbiological deviations, OOL results and implementing CAPAs.
*Excellent communication, problem-solving and stakeholder management skills.