Description
CQV Engineer required to join a biotech project supporting the downstream equipment. The CV engineer will be responsible for the Buffer Preparation and Buffer Hold, UF/DF, Chromatography, initially responsible for review of all Design deliverables from JE including Drawings, Datasheets, specifications and Engineering Lists.Role and responsibilities:
- Aligning with JE on System boundaries and Lead and review exercise.
- Point CQV person for Vendor review for all Downstream Vendor Packages.
- Assist CQV SME for all LSCC Downstream Systems.
- Liaise with JE in relation to construction readiness and a schedule for all Downstream systems, perform and lead all field walk downs for all Downstream 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 LSCC Building for Downstream.
- Liaise with CQV SWAT Team in relation to punchlist closure both pre-M/C and during the CQV execution phase for Downstream systems within Building.
- Liaise with CQV PM and Lead Scheduler in relation to schedule creation and management for all LSCC Systems, ensuring all correct predecessors and successors are in place for Downstream Equipment.
- Ensure Commissioning readiness of all LSCC Downstream Systems to support Equipment Start-up and IOQ Testing.
- Liaise with all Project Groups (Design/CM/CQV/Automation/Process/SMEs/Ops/Maintenance/PMs) to ensure all LSCC Downstream Systems are managed appropriately for the entire Project Lifecycle.
- Liaise with CQV Document Generation Lead in relation to generation and approval of; DQ/Design Reviews/SLIA/Test Matrices/Risk Assessments/QA Vendor Assessments/FAT/SAT/CTP/IOQ Protocols
- Support execution of all LSCC Downstream CQV deliverables; FAT/SAT/CTP/IOQ
- Support Weekly CQV Downstream LSCC Meeting and ensure updates are provided to Weekly CQV Meeting.
- Generate and ensure timely approval of all Commissioning and IOQ Final Reports for Downstream Equipment
- Working knowledge of ASTM E2500/Leveraging Verification process
- Experience with liaising with other departments and building PMs/leads
- 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)