Job Title: Senior Sterilisation Engineer
Key Responsibilities:
* Conduct research and feasibility trials for the sterilization of new products.
* Engage with global vendors to plan and manage process transfers.
* Develop protocols, oversee vendor testing, and analyze data.
* Lead design reviews and recommend optimal sterilization procedures.
* E nsure compliance with Good Manufacturing Practice (GMP) standards.
Requirements:
* Experience in development, validation & commercialization of various sterilization modalities such as Steam, Ethylene Oxide (EtO), Gamma, E-beam, and X-ray (Steam and EtO preferred).
* Experience in development & validation of sterilization methods for liquids, pre-filled syringes, polymers, combination medical devices (drug delivery), and pharmaceuticals.
* Familiarity with sterilization-specific and industry standards including: