Description
The CQV Engineer will be required to support the current CQV team with the execution activities. Specifically, within Bioreactors, both seed and production, Centrifuges, Harvest. The engineer will be responsible for driving the field execution, IOC, IOC and final reports.Role and responsibilities:
- Liaise with CQV PM and Lead Scheduler in relation to schedule creation and management for all Systems, ensuring all correct predecessors and successors are in place.
- Liaise with CQV start-up team in relation to punch list closure both pre-mechanical completion and during the CQV execution phase.
- Ensure Commissioning readiness of all 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 Systems are managed appropriately for the 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.
- Ensure timely approval of all Commissioning and IOQ Final Reports.
- Minimum of 3 years' experience including experience with design and construction projects for biopharmaceutical manufacturing facilities.
- Experience with complex projects and working in or around operating facilities.
- Experience within Bioreactors, both seed and production, Centrifuges, Harvest.
- 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 communication skills. Problem solver with a focus on achievement of overall project goals.
- Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Project).