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Sterilization Engineer

Ref: 9222699

  • Negotiable DOE
  • 12 Apr 2021
  • Westmeath
  • Perm
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A leading Medical Device manufacturer in the Midlands requires an experienced Sterilization Engineer. The Senior Sterilization Engineer/Microbiologist requires strong knowledge of Ethylene Oxide Sterilization per ISO 11135 and is the site subject matter expert for the EO sterilization process & associated cycles.

About the Job:

• 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.

About You:

  • Bachelor of Science degree is required (Level 8). Master’s degree in Microbiology or other life sciences is preferred.
  • 5+ years of medical device industry experience in sterilization.
  • 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.

    • Specialist Knowledge:

    • 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. • Good oral and written communication skills.

    For more on the role call Nigel on 087 3618142 or send your CV for consideration.
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