Job Description
Sterility Assurance Lead - Expanding Biopharma Manufacturer We are seeking an experienced Sterility Assurance Lead to join an expanding biopharma manufacturer. In this role, you will own the site's Contamination Control Strategy and ensure compliance with sterility assurance regulations. Key Responsibilities: Lead the site's Contamination Control Strategy. Collaborate with operations to develop a robust aseptic processing training programme. Establish the site's gowning strategy and oversee the cleaning and sanitisation programme. Monitor and analyse microbiological data to identify trends. Provide technical guidance on contamination-related non-conformances and events. Ensure compliance with sterility regulations and act as the SME for sterility assurance during regulatory inspections. Offer technical input for the transfer of microbiological test methods. Experience Required: Degree in a relevant technical discipline (Microbiology qualification desirable). Minimum 4 years' experience in Quality/Operations within the pharmaceutical or biopharma industry. At least 1 year of aseptic sterile fill-finish manufacturing experience. Experience in a microbiological function within an aseptic sterile fill-finish facility The Next Step for you: Should this position be of interest to you please forward your CV to Sarah Mac Mullan from Next Generation Recruitment or alternatively call on the main line on Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical and Operation (permanent, contract and temporary) positions. Applications are in strict confidence. Next Generation will never share your data outside of our organisation without your prior written consent. Please read our Data Protection Policy on our website. Skills: Aseptic Biopharma QC Sterility Assurance