Summary
The Sterilisation Manager is responsible for ensuring compliance with applicable Corporate and Divisional policies, procedures, and regulatory requirements. This role provides strategic and technical leadership for sterilization processes, validations, and investigations across the product lifecycle.
Key Responsibilities
-Lead and manage a team responsible for sterilization qualification of new products and changes to existing products.
-Oversee sterilization validation activities for radiation-sterilized products, including dose setting and quarterly dose audits.
-Oversee sterilization validation activities for ethylene oxide (EO)–sterilized products, including new product qualification, annual revalidations, EO residual studies, and D-value studies.
-Serve as the primary Sterilization Subject Matter Expert (SME), providing technical support to Product Development and Operations teams.
-Lead team participation in Supplier Quality audits of contract sterilization facilities and third-party manufacturers.
-Direct investigations related to radiation dose audit failures and ensure appropriate corrective and preventive actions are implemented.
-Lead investigations of EO biological indicator sterility positives and ensure regulatory compliance and risk mitigation.
Education
-Bachelor’s degree with 9+ years of relevant work experience, or an equivalent combination of education and experience.
-Advanced degree preferred.
Experience & Qualifications
-Extensive knowledge of radiation and/or ethylene oxide sterilization modalities (additional modalities a plus).
-Recognized Subject Matter Expert within the work
