ProClinical is working with a global leading biopharmaceutical company that is seeking a CQV Clean Utilities Engineer for their large-scale biologics manufacturing facility. The CQV Engineer for Clean Utilities (WFI, Clean Steam, Clean Compressed Air, Gases and WFI) will also supporting the HVAC systems, and be initially responsible for review of all Design deliverables from Contractor including Drawings, Datasheets, specifications and Engineering Lists. This is a 12-month contract role based in Basel Switzerland and Huningue, France.
- Aligning with Contractor on System boundaries, point CQV person for Vendor review for all Black, Clean Utilities and HVAC Vendor Packages
- Assist CQV SME for all Black, Clean Utilities and HVAC Systems
- Liaise with Contractor in relation to construction readiness and a schedule for all Black, Clean Utilities and HVAC systems, perform and lead all field walk-downs for all systems
- Assist CQV review, aligning with Transition Group in relation to review and approval of all Turnover Packages, both Vendor and Contractor Packages within the Black, Clean Utilities and HVAC scope
- Liaise with CQV SWAT Team in relation to punchlist closure both pre-M/C and during the CQV execution phase for all Black, Clean Utilities and HVAC systems
- Liaise with CQV PM and Lead Scheduler in relation to schedule creation and management for all Process Equipment Support, ensuring all correct predecessors and successors are in place
- Ensure Commissioning readiness of all Black, Clean Utilities and HVAC Systems to support Equipment Start-up and CQV Testing
- Assist PSSR/STW field execution and guide CQV Team through Start-up exercise in a safe and controlled manner
- Assist CQV Black, Clean Utilities and HVAC with EIDA/or Master Project Database equivalent system, ensure full traceability at all times for all systems
- Liaise with all Project Groups (Design/CM/CQV/Automation/Process/SMEs/Ops/Maintenance/PMs) to ensure all Black, Clean Utilities and HVAC Systems are managed appropriately for the entire Project Lifecycle
- Liaise with CQV Document Generation Lead in relation to generation and approval of; Design Reviews/SLIA/Test Matrices/FAT/SAT/CTP Protocols
- Support execution of all Black, Clean Utilities and HVAC CQV deliverables; FAT/SAT/CTP
- Assist with weekly CQV Black, Clean Utilities and HVAC Meeting and ensure updates are provided to Weekly CQV Meeting
- Generate and ensure timely approval of all SAT and or CTP Final Reports
Skills and Requirements:
- Minimum 5 years CQV Black, Clean Utilities and HVAC experience on Large Scale Projects
- Working knowledge of ASTM E2500/Leveraging Verification process
- Experience with liaising with other departments and building PMs/leads
- Minimum of 5 years of Black, Clean Utilities and HVAC experience including experience with design and construction projects for biopharmaceutical manufacturing facilities
- Minimum 5 years’ experience in Black, Clean Utilities and HVAC CQV Team
- Experience with complex projects and working in or around operating facilities
- Ability to keep work pace and meet deadlines. Good organising 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)
- fluent in spoken and written English and French
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nick Dietz on +44 203 3193 033 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.