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