Sterilisation Manager

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 Suppl...