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Sterilization Process Manager

3 weeks ago

Cork, Cork, Ireland beBee Careers Full time

Our business focuses on developing innovative vascular devices to treat various heart and blood vessel conditions.

Purpose:

The Sterilization Manager plays a crucial role in ensuring compliance with corporate policies and procedures.

Key Responsibilities:

  • Led a team responsible for sterilization qualification of new products and changes to existing products.
  • Lead a team performing sterilization validation for radiation-sterilized products, including dose setting and quarterly audits.
  • Leads a team that performs sterilization validation for ethylene oxide-sterilized products, including new product qualification, annual revalidations, residual EO studies, and D-value studies.
  • Provides sterilization Subject Matter Expert support to product development and Operations teams.
  • Assisted in Supplier Quality audits of contract sterilization facilities and third-party manufacturers.
  • Conducted dose audit failure investigations.
  • Investigated Ethylene Oxide Biological indicator sterility positive results.

Education:

A bachelor's degree plus 9+ years of experience in a related field is required, or an equivalent combination of education and experience. An advanced degree is preferred.

Experience:

  • Substantial knowledge of radiation, ethylene oxide, or other sterilization modalities.
  • Utilizes in-depth knowledge of business unit functions and cross-group dependencies/relationships.
  • Leads a technical team in executing sterilization validation/revalidation, new product qualification, and troubleshooting sterilization issues.
  • Works on complex problems requiring in-depth evaluation of various factors.
  • Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.