Our client is making a significant capital investment for a new biologics facility in the USA and requires a CQV Lead to work on the multi-billion-dollar project.
- CQV Lead Engineer for all Upstream & Downstream systems (Inoc, Media, Cell Culture, Harvest, UF-DF-Depth Filter-Viral Filter-Chromo-Purification-etc), initially responsible for timely review and approval of all CQV documentation, including but not limited to – EDR-DQ, SIA, FAT, RTM, QRA, RV, SAT, IOC, IOQ and Final Reports.
- Review of all Design deliverables from EPCM, including Drawings, Datasheets, specifications and Engineering Lists. Also assist in GMP reviews. Author all CQV sub plans (VPP) for Upstream/Downstream Areas. Review of all GMP generated documentation via the KNEAT system.
- Liaise with the CMMS Team from day 1 to ensure timely transition of GMP information into the CMMS system.
- Aligning with EPCM and CQV Turnover Lead in relation to System boundaries and Lead and review exercise.
- Point CQV person for Vendor review for all Upstream/Downstream Vendor Packages.
- CQV SME for all Upstream/Downstream Systems.
- Liaise with EPCM in relation to construction readiness and a schedule for all Upstream/Downstream systems. Lead CQV effort for schedule review and readiness. Also perform and lead all field walk-downs for all Upstream/Downstream systems.
- Lead CQV review, aligning with Transition Group in relation to review and approval of all Turnover Packages, both Vendor and Contractor Packages within the Upstream/Downstream Areas.
- Liaise with CQV SWAT Team in relation to punchlist closure both pre-M/C and during the CQV execution phase for Upstream/Downstream Systems.
- Liaise with CQV PM and Lead Scheduler in relation to schedule creation and management for all Upstream/Downstream Systems, ensuring all correct predecessors and successors are in place.
- Ensure Commissioning readiness of all Upstream/Downstream Systems to support Equipment Start-up and IOC-IOQ Testing.
- Lead PSSR/STW field execution and guide CQV Team through Start-up exercise in a safe and controlled manner.
- Liaise with all Project Groups (Design/CM/CQV/Automation/Process/SMEs/Ops/Maintenance/PMs) to ensure all Upstream/Downstream Systems are managed appropriately for the entire Project Lifecycle.
- Lead execution of all Upstream/Downstream CQV deliverables; FAT/SAT/CTP/IOQ.
- Generate and ensure timely approval of all Commissioning and IOQ Final Reports.
If this role interests you, apply today.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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