Description
We have a long term contract requirement for an experienced C&Q Engineer to work on the CQV of the Utilities (Test & Balance) HVAC & Water SystemsWorking on a large scale new state of the biologics manufacturing facility we are looking for experienced C&Q Engineers with previous Pharmaceutical/Biopharmaceutical Industry experience
Key responsibilities will include:
- Document prep (Test Matrices, DQ, Risk Assessments, Safety Start-up documentation, CTPs, IOQs, PQs)
- Responsible for validating, at a minimum, HVAC, Compressed Gases systems, Water systems and Steam systems.
- Coordinating and monitoring the validation/project phases and informing management of project progress.
- Creating and executing protocol test scripts in accordance with cGMP, regulatory requirements, the Computer System Validation Master/Project Plan, and Policies, Procedures & Guidelines to ensure robust tested systems, which are fit for use.
- Assisting in audit preparation and presentation of the above systems for internal, vendor and regulatory audits.
- 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.
- Support execution of all CQV deliverables; FAT/SAT/CTP/IOQ
- Document prep (Test Matrices, DQ, Risk Assessments, Safety Start-up documentation, CTPs, IOQs, PQs)
- Must have Utilities experience in both HVAC and Water Systems
- Start-up, walk downs, set-to-work
- Commissioning and Qualification execution of the above systems from MC to PQ
- Experienced with vendor coordination for VPE.