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Validation Engineer

  • Team Horizon
  • Roscommon

To apply for this job email your details to ashling.guthrie@teamhorizon.ie

Why you should apply:

  • This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
  • Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.

What you will be doing:

  • Owning the line qualification lifecycle document using risk-based verification approach (ASTM E2500)
  • Managing the vendor SAT testing and executing against verification test scripts
  • Overseeing of the Vendor VHP CD/PQ
  • Supervising the autoclave sterilization cycle (cycle development and PQ) for the format contact parts
  • Driving and execution of the air visualization studies

What you need to apply:

  • Bachelor’s degree required as a minimum
  • 9+ Years of experience
  • Knowledge of the risk-based qualification approach, applied knowledge of ISPE C&Q and ASTM E2500
  • Experience of the filling isolator concept
  • Hands-on experience with installation and verification test execution
  • Non-touch-transfer technology experience
  • Understanding of the VHP cycle development and performance qualification
  • Autoclave sterilization of the porous loads knowledge
  • Good project management skills
  • Strong communication skills

To apply for this job email your details to ashling.guthrie@teamhorizon.ie