Manufacturing and Validation Specialist

2 days ago


Cork, Cork, Ireland beBeeValidation Full time €60,000 - €80,000
Job Description

We are seeking a skilled professional to support a site expansion project in the medical device industry. The consultant selected will have experience in validating cleaning equipment and lines, as well as decommissioning and commissioning new production lines.

The ideal candidate will possess hands-on experience with creating User Requirements Specifications (URS) and executing Factory Acceptance Tests (FAT), System Acceptance Tests (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Key Responsibilities
  • Validate cleaning equipment and lines in medical device environments.
  • Decommission and commission new production lines from scratch, including creating URS and executing FAT, SAT, IQ, OQ, and PQ.
  • Lead and manage end-to-end validation projects from planning through execution and handover.
Required Skills and Qualifications
  • Experience validating cleaning equipment/lines in Medical Device or Pharma settings.
  • Hands-on experience decommissioning and commissioning new production lines (URS, FAT, SAT, IQ, OQ, PQ).
  • Proven track record delivering full end-to-end projects from a Validation perspective.
What We Offer
  • Contract duration: initial 12 months, with potential extension to 2-3 years.
  • Opportunity to work on high-profile projects in the medical device industry.
Location

Carrigtwohill, County Cork, Ireland.



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