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CQV Engineer
3 months ago
CQV Engineer
2 Positions, I FTC and I permanent
Midwest/Sligo Ireland.
This biotech company are fast tracking their move into full scale production and are on the ramp up in all areas, they are seeking to hire two CQV Engineers to join their team. This is an exciting time to join as you will gain a lot of exposure and gain experience putting your stamp on the process.
Key Responsibilities
The CQV Engineer will be responsible for planning, generation, execution and reporting of Commissioning, Qualification and Validation (CQV) of facility, utilities and process equipment. The role will support both new and legacy equipment.
Desired Experience
- At least 3 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.
Responsibilities
- 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 (functional) tests.
- Participate in startup activities of energized equipment when necessary.
- Perform system P&ID walkdown with construction prior to handover. Categorization of punch list items & tracking to completion.
- Assist in investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents.
- Liaise with the various stakeholders on the Project team and the overall project to ensure clear communication between all parties.
- Participation in and execute design reviews (DQ), when required.
- Review and Input into deliverables such as technical requirement specifications and vendor turnover documentation.
- Manage the site attendance for the vendors, contractors and specialist contractors.
- Liaising with Construction management team to ensure completion of mechanical completion packs, review of all contractors packs for traceability, review of all supporting vendor documents in timely manner to support execution.
- Where necessary attendance at FAT's at Vendor Sites anticipated to be in mainland Europe.
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