Summary: The CQV Upstream Engineer – Commissioning role is focused on supporting the commissioning and qualification of upstream systems in a new pharmaceutical manufacturing facility in North Carolina. The position involves extensive collaboration with various teams and vendors, ensuring that all design deliverables and documentation are aligned with project requirements. The engineer will lead field execution and manage schedules to ensure readiness for equipment start-up and testing. This is a critical role within a growing organization that emphasizes quality and safety in its operations.

Key Responsibilities:

• Senior CQV Engineer for Equipment in the Upstream Area for the DSM Building, initially responsible for review of all Design deliverables from Jacobs including Drawings, Datasheets, specifications and Engineering Lists.
• Support generation of all CQV Upstream Documentation – FAT wraparounds, DQ, RTM, QRA, SAT/IOC and IOQ, including Final Reports.
• Generate Upstream Bridging document, ensuring full alignment with Process Science (PS) in relation to supply of CPPs and CQAs.
• Point CQV person for Vendor review for all Upstream Vendor Packages. CQV SME for all Upstream Systems.
• Liaise with Jacobs in relation to construction readiness and a schedule for all Upstream systems, perform and lead all field walkdowns for all 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 Process Equipment Support scope. Liaise with CQV SWAT Team in relation to punchlist closure both pre-M/C and during the CQV execution phase for all Process Equipment Support systems.
• Liaise with CQV PM and Lead Scheduler in relation to schedule creation and management for all Upstream Systems, ensuring all correct predecessors and successors are in place.
• Ensure Commissioning readiness of all Upstream Systems to support Equipment Start-up and IOQ Testing.
• Lead PSSR/STW field execution and guide CQV Team through Start-up exercise in a safe and controlled manner.

Key Skills:

• Extensive CQV experience
• Can work independently
• Ability to travel for FAT’s
• Experience with liaising with other departments and building PMs/leads
• Extensive equipment experience including experience with design and construction projects for biopharmaceutical manufacturing facilities.
• Extensive experience in Leading Equipment CQV Team
• Experience with complex projects and working in or around operating facilities.
• Ability to keep work pace and meet deadlines. Good organizing and planning skills.
• Demonstrated proficiency communicating and collaborating at a variety of levels with customers, vendors, equipment suppliers and operations staff.

Salary (Rate): undetermined

City: undetermined

Country: United States

Working Arrangements: undetermined

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other