Sterilization Engineer

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 provide assistance 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 in compliance with 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.

1-3 years 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 TIR 15 TIRand FDA and Country specific guidelines to the medical devices and surgical.
Good communication skills and able to lead a team.