Sterilisation Manager New

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.

• 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.

• Serve as the primary Sterilization Subject Matter Expert (SME), providing technical support to Product Development and Operations teams.

• 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.

• Bachelor’s degree with 9+ years of relevant work experience, or an equivalent combination of education and experience.
• Advanced degree preferred.

• Extensive knowledge of radiation and/or ethylene oxide sterilization modalities (additional modalities a plus).
• Recognized Subject Matter Expert within the work