Senior Validation Engineer – an excellent opportunity to join a leading medical device organisation based in Galway working on Sterilization Validation Protocols.

Key Responsibilities:

  • Creation and approval of Sterilization Validation Protocols and Report.
  • Review and approval of test results and associated test method validations.
  • Collaboratively works with external contract sterilization test facility.
  • Assess/Coordinate cycle consolidation opportunities.
  • Support Operations and Design Service Project Teams.
  • Management of process deviations, NCRs and CAPAs related to Sterilization Processes.
  • Support of operations and design service project teams.
  • Knowledgeable of the associated Quality System requirements.
  • Responsible for maintenance of site Sterilization and Controlled Environment procedures.
  • Conduct supplier auditing as required.
  • Ownership of site product bioburden program.
  • Management of the site environmental monitoring program.
  • Gives guidance on cleanroom control.
  • Assess changes to products and processes for impact on sterilization.

 

Requirements: 

  • BSc. in Science/Engineering.
  • 5 years experience in the medical device or pharmaceutical.
  • Knowledge of medical device products and regulations.
  • Experience in industrial ethylene oxide sterilization.
  • Microbiological experience in environmental monitoring, and laboratory procedures preferred.
  • Auditing experience.
  • Familiarity with regulations such as FDA, USP, AAMI, ANSI, ASTM, and ISO.
  • Familiarity with the operation and maintenance of environmentally controlled manufacturing and testing facilities.
  • Knowledge and experience of Ethylene Oxide Sterilisation validation and routine control.
  • Knowledge of Microbiological and Environmental monitoring programs.
  • Ability to effectively communicate both internally and externally.
  • Ability to read and interpret documents.
  • Must be authorised to work in Ireland.

 

Please contact Emer Moore to discuss in confidence
00353578638188       
emoore@emtechrecruitment.ie

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