Description
CQV Engineer - Downstream to support the current CQV team with the execution activities to be based in Dublin on an initial 6-month contract.Specifically, supporting Media Prep, Buffer Prep and Buffer Hold, purification, fermentation, filtration, dia-filtration, ultra-filtration, chromatography, chromatography column, harvest tank, vessel, tanks, skids. 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.
- CQV interface with EIDA/or Master Project Database equivalent system, ensure full traceability at all times for all LSCC systems.
- 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
- Execution of all LSCC CQV deliverables; IOQ, field execution
- 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 Media Prep, Buffer Prep and Buffer Hold, purification, fermentation, filtration, dia-filtration, ultra-filtration, chromatography, chromatography column, harvest tank, vessel, tanks, skids 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 communication skills. Problem solver with a focus on achievement of overall project goals.
- Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Project).