Sterilization Engineer

Job Description

• Bachelor's degree ( Microbiology/Biology/Physics/ Chemistry), relevant discipline, or equivalent.

• 1-3 years of working experience in medical device manufacturing or similar GMP environment
• Prior experience working with ethylene oxide and gamma sterilization processes
• Pharmaceutical Industry GMPs. Interpret & Apply ISO 11135, 11137, TIR 15, TIR 28, 11737, and FDA and Country specific guidelines to medical devices and surgical.
• Good communication skills and ability to lead a team.
• Prior experience working with ethylene oxide and gamma sterilization processes -Pharmaceutical Industry GMPs. Interpret & Apply ISO 11135, 11137, TIR 15, TIR 28, 11737 and FDA and Country specific guidelines to the medical devices and surgical

• Supports and collaborates with the project team for validation efforts right from inception, design-build, test, and implementation
• Investigate/troubleshoot validation discrepancies for systems and/or performance processes
• Author and coordinate validation protocols- IQ/OQ/PQ
• Support ethylene oxide requalification activities to meet ISO requirements on time
• Create change controls and help in determining root cause for non-conforming events and evaluate CAPAs for effectiveness
• Ensures required processes and procedures are followed to support validation programs and are following regulations
• Co-operates with all departments through open, candid communication and collaboration
• Knowledge of statistical analysis to assess control and manage risks of product quality and determine the responsibility for products or materials that do not meet required standards and specifications.