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Commissioning and Qualification Expert

2 weeks ago

Limerick, Limerick, Ireland CAI Full time
About This Opportunity

We are looking for a highly skilled CQV Engineer to join our team in Ireland. As a key member of our team, you will be responsible for conducting and leading Commissioning, Qualification, Validation activities with a direct regard for Safety.

What You Will Do

  • Lead Commissioning, Qualification, Validation team activities with a focus on Safety.
  • Manage C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.
  • Generate C&Q Procedures for projects.
  • Approve TOPs.
  • Facilitate scoping/planning of commissioning spares and consumables.
  • Deliver C&Q activities as required to meet the schedule.
  • Track progress of C&Q activities as required.
  • Prepare Qualification Summary Reports (QSR) and manage Requirement Traceability Matrix (RTM).

What We Are Looking For

  • BS or MS in a relevant science or engineering field, or equivalent.
  • 3+ years in CQV SME roles for life sciences – Clean Utilities/Filling experience preferable.
  • Excellent oral and written communication skills.
  • Excellent problem-solving skills.
  • Customer-service focused.
  • Proficient in life science manufacturing processes in areas such as biotech, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.
  • Able to travel domestically and internationally if required.