Sterility Assurance Specialist

Sterility 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.