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Process Validation Expert

2 weeks ago

Limerick, Limerick, Ireland CAI Full time

About CAI:

CAI is a 100% employee-owned company that has grown exponentially to nearly 700 people worldwide, providing commissioning, qualification, validation, start-up, project management, and consulting services related to operational readiness for FDA regulated and other mission-critical industries.

Meeting a Higher Standard

We put the client's interests first, and we will do whatever it takes to get there. Our approach is simple and effective.

As owners of CAI, we are committed to living our Foundational Principles professionally and personally:

  • Act with integrity
  • Serve each other
  • Serve society
  • Work for our future

We work diligently to accomplish team goals, placing Team Before Self, demonstrating Respect for Others, and possessing a can-do attitude.

Career Opportunities

You will have an opportunity to work with recognized subject matter experts, allowing you to be a key player in bringing lifesaving therapies to market. As part of our company culture, we invest in YOUR future and commit to hands-on certifications as well as professional training.

Job Requirements

We are now seeking a CQV/Validation Engineer to join our growing operations in Ireland. The role involves conducting and leading Commissioning, Qualification, Validation team activities with a direct regard for Safety.

  1. Manage the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.
  2. Generate C&Q Procedures for projects.
  3. Approve TOPs.
  4. Facilitate scoping/planning of commissioning spares and consumables.
  5. Deliver the C&Q activities as required to meet the schedule.
  6. Track progress of C&Q activities as required.
  7. Prepare Qualification Summary Reports (QSR), and manage Requirement Traceability Matrix (RTM).