The Senior Sterilization Engineer requires strong knowledge of Ethylene Oxide Sterilization per ISO 11135 and is the site subject matter expert for the EO sterilization process & associated cycles.
- Manage the Ethylene Oxide Sterilization as per ISO 11135. This includes validations, re-qualifications, and release of routine production loads.
- Responsible for maintaining compliance to all regulations and standards relevant to job responsibilities.
- Manage technical projects from protocol development, laboratory testing, data analysis through final report generation.
- Manage environmental trending as required by regulations to ensure compliance for critical systems.
- Develops, validates, and implements controlled environment methods.
- Perform various microbiological or chemical evaluations encompassing USP/AAMI biological testing, ETO residuals and other alternative sterilization methods.
- All activities must be performed in compliance with the Quality System.
Bachelor of Science degree is required (Level 8). Master’s degree in Microbiology or other life sciences is preferred.
Required Years of Experience:
5+ years of medical device industry experience in sterilization.
- General maths, general and analytical chemistry knowledge.
- Strong knowledge of Ethylene Oxide Sterilization as per ISO 11135. This includes validations, re-qualifications, and release of routine production loads.
- Excellent technical writing skills.
- Knowledge of industrial microbiology, microbiological quality control, medical device sterilization methods, and medical device GMPs.
- Knowledge of applied microbiological theory and practices including inactivation kinetics, and medical device sterilization methods.
- Microbiology laboratory skills including volumetric measurement, media preparation, microbial enumeration techniques, autoclave operation and laboratory safety.
- Basic maths, algebraic maths, with ability to calculate serial dilutions, scientific exponents, proportional concentrations and graphing skills.
- Knowledge of Cleanroom environmental monitoring.
- Computer skills.
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