CQV Engineer
- Sligo
- Contract
- Full-time
- You enjoy working on exciting projects and want to work with a global manufacturing site in Sligo.
- Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
- Prepare, execute and report on CQV activities for assigned systems to include C&Q Planning, URS generation, DQ facilitation, TM/RTM, FAT, SAT, IQ, OQ and where applicable PQ activities.
- Prepare, review and approve project documentation, ensuring technical accuracy and adherence to cGMP.
- Support design reviews and system risk assessments with multiple stakeholders.
- Confirm all vendor documentation executions are compliant with GxP practices and the executed documentation is acceptable to support CQV.
- Complete field verifications during static and dynamic Participate in startup activities of energized equipment when necessary.
- Interaction with vendors for project planning.
- Perform system P&ID walkdown with construction prior to handover. Categorization of punch list items & tracking to completion.
- Support review on all Isometrics, Weld logs, Weld Qualifications, 3rd Party Inspections, Material of Construction and Redlining exercise.
- Confirm the site installation is as per approved design specification and meet system IQ requirements.
- Any other duties as assigned.
- A minimum of a Honours degree in an Engineering or Science discipline.
- At least 5 years’ experience in the biotechnology and/or pharmaceutical industry, in a CQV role.
- Proven experience in authoring, review and execution of CQV activities on a variety of Facility, Utility and Process Equipment is essential.
- Experience with clean utilities and aseptic processing facilities would be an advantage.
- Experience in Computer Systems Validation is desirable.
- Experience in temperature mapping of temperature control devices and sterilization cycles is desirable.
- Proficient in written and spoken English.