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Validation Engineer

4 months ago


San Jose, United States Procal Technologies Full time

RoleThe Validation Engineer will be responsible for completing the commissioning and qualification activities for the equipment and systems included in a new Sterility Suite at one of our clients. The Sterility Suite will be created as part of a facility upgrade project to reconfigure an existing space into a new Grade D clean suite. The qualification will include commissioning qualification and validation (CQV) of the new suite and the Environmental Monitoring PQ (EMPQ) of the space. The project also includes CQV of the following equipment and systems· Air Handling Unit - Commissioning/IOQ/Integration with Building Automation System (BAS)· 2 Isolators - Commissioning/IOQ/EMPQ/Vaporized Hydrogen Peroxide (VHP) PQ· 4 Incubators - Commissioning/IOQ· 1 Refrigerator - Commissioning/IOQEstimated duration of the project is 6 months for a team of 2 resources with most of the work being completed onsite at the client’s facility in Southern California.Responsibilities· Generate and route for approval the Commissioning & Qualification Protocols for the equipment/system.· Generate and route for approval the test cases required for the equipment/system.· Support the execution resolution