Summary:
The Sterilization Engineer is responsible for intermediate activities related to Development Services product and process development, fabrication, and sterilization of materials as work order needs dictate. The ideal candidate should have 7+ years of relevant experience in sterilization engineering within pharmaceutical or medical device environments.
Roles & Responsibilities:
• Turnover, controls, care, and custody from EPCM to client.
• Signature authority on equipment turnover.
• Following paper trail of turnover package from start to finish.
• Support sterilization process development and validation activities.
• Coordinate with cross-functional teams for project execution.
• Greenfield/Brownfield project experience preferred.
Education & Experience:
• EO Sterilization Validation (ISO 11135).
• EO Residual Testing (ISO 10993-7).
• EO Sterilization Cycle Optimization (ISO 11135).
• Process Challenge Device Development (ISO 11135).
• Radiation Sterilization (ISO 11137).
• Pharma / Biopharma / Medical Device industry experience required.
• Experience handling commissioning, qualification, validation, and turnover documentation.
