CQV Engineer

Team Horizon is seeking a CQV Engineer for a leading manufacturing company in Sligo.

The CQV Engineer will be responsible for planning, generation, execution and reporting of Commissioning, Qualification and Validation (CQV) of facility, utilities and process equipment.

This role will support both new and legacy equipment. The candidate must be a self-starter with significant professional experience design, commissioning, qualification and continuous improvement of pharmaceutical facilities, utilities and equipment.

Why you should apply:

• 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.

What you will be doing:

• 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.

What you need to apply:

• 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.