CQV CIP Engineer - North Carolina - 12-Month Contract
Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for a CQV CIP Engineer to join their new and exciting large-scale CAPEX investment programme. With a mission to provide process development and cGMP production in cell culture, microbial fermentation, and gene therapies, this is an outstanding opportunity make a genuine contribution to the biopharmaceutical industry.
Responsibilities:
- CQV Support Engineer for all CIP Equipment in the DSM Buildings, initially responsible for review of all Design deliverables from Jacobs including Drawings, Datasheets, specifications and Engineering Lists.
- Support generation of all CQV CIP Documentation – FAT wraparounds, DQ, RTM, QRA, SAT/IOC and IOQ, including Final Reports.
- Point CQV person for Vendor review for all CIP Vendor Packages.
- CQV SME for all CIP Systems. Produce CIP Bridging to include all CCP, CQAs and worst case information of circuits.
- Support all circuit reviews for all CIP routes and circuits, working out “worst case” scenarios for testing and cleaning requirements.
- Liaise with construction manager in relation to construction readiness and a schedule for all CIP systems, perform and Support all field walkdowns for all systems.
- Support 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 Support Scheduler in relation to schedule creation and management for all CIP Systems, ensuring all correct predecessors and successors are in place.
- Ensure Commissioning readiness of all CIP Systems to support Equipment Start-up and IOQ Testing.
Requirements:
- Extensive Equipment experience on Large Scale Biopharmaceutical Projects
- SME on all CIP Systems, minimum 5 years
- Working knowledge of ASTM E2500 / Leveraging Verification process
- Experience with liaising with other departments and building PMs/leads
- Minimum of 10 years of Equipment experience including experience with design and construction projects for biopharmaceutical manufacturing facilities.
- Minimum 5 years experience on 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.
- Proven success working well in a team environment with flexibility to react to changing business needs.
- Strong leadership and communication skills. Problem solver with a focus on achievement of overall project goals.
- Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Project)
If this role is of interest to you, please apply now!
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