Medical Device Sterilization SME

Charlotte, NC

Industry: Med Job Number: 129645

Medical Device Sterilization SME 

Environment:

Our client is a large medical device manufacturer. They are in need of a Sterilization Specialist with a background in Ethylene Oxide Sterilization.

Duties/Responsibilities/Scope of Work

This individual will come from a Medical Device background, and must have strong, hands-on experience in  Ethylene Oxide Sterilization.(commonly known as EtO Sterilization or EO Sterilization). This individual will be responsible for comparing new product changes against legacy products and their validation testing requirements in order to create a Sterilization Testing Rationale for their new products (ie. what should be tested, how should it be tested, etc.). This individual must be comfortable with EtO Sterilization Validation, and should be familiar  with the following standards:

ISO 17664, ISO 17665, TIR 30, TIR 12, ISO 11737-1, ISO11737-2,  ISO 11138-1, ISO 15883-1, ISO 15883-2, ISO 15883-5, ANSI/AAMI ST77, ISO 11138-

Required Experience:
  • Medical Device 
  • Ethylene Oxide Sterilization (known as EtO Sterilization or EO Sterilization)
  • Sterilization Validation
  • Writing Sterilization Testing Rationale

Plus:
  • Microbiology background is plus

Job Type: Contract  

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