Sterility Assurance Specialist

Leading and maintaining robust sterility assurance and environmental monitoring programmes in line with GMP Acting as the subject matter expert providing guidance across the business Supporting and driving continuous improvement initiatives. Leading and contributing to investigations (deviations, non-conformances, complaints) and acting as a technical approver Interpreting and trending microbiological and environmental monitoring data. Monitoring and reporting quality metrics to support performance and compliance Supporting validation activities, including microbiological methods and sanitisation processes Managing external laboratory relationships.

Developing and maintaining quality documentation Delivering microbiological and aseptic training and mentoring colleagues across teams Degree in Microbiology (or equivalent experience) Proven experience in aseptic manufacturing or sterile environments Strong background in environmental monitoring and sterility assurance programmes Experience investigating out-of-limit results, deviations, and quality incidents Knowledge of GMP and regulatory standards within a healthcare or pharmaceutical setting Skilled in data interpretation, problem-solving, and continuous improvement Confident working independently, with strong critical thinking and decision-making skills Excellent communication and collaboration abilities, with a passion for quality