Senior Sterilisation Engineer

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.

Required Education:

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.

Required Knowledge:

• 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.

Desired Qualifications

• 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.

For more information please call me on 087 9728431 or annemarie@amfconsulting.ie

Feel free to contact me for open jobs in Westmeath or engineering jobs