Validation Engineer

Role:

The 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/IOQ

Estimated 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 of discrepancies/deviations, and approval of the test case required for the equipment.

· Support updates to equipment and system lifecycle documentation, as needed.

· Support VHP cycle development for Isolators as required.

· Generate and route for approval the CQP Reports.

· Maintain training current on relevant SOPs.

· Daily accounting of time and activities submitted to PM weekly.

Qualifications/Required Skills:

· 4-year degree in Engineering, Life Sciences, or similarly related field.

· 5 years of experience with Commissioning, Qualification, and Validation (CQV) in in the Life Sciences/FDA Regulated Industries including utilities, facilities, and equipment

· Experience interpreting and updating Life Cycle Documentation including User Requirements (URS), System Specification (SS), System Risk Assessments (SRAs), and Design Qualifications (DQ)

· Experience generating and executing Commissioning/Qualification protocols for Cleanrooms and HVAC systems, Air Handling Units (AHU), Building Management/Automation Systems.

· Experience generating and executing Environmental Monitoring PQs.

· Experience with VHP cycle development and generation and execution of VHP PQ protocols

· Experience with commissioning/qualification of thermal chambers (incubators and refrigerators) including temperature mapping, use of Kaye Validator or equivalent test instruments.

· Excellent Written and Verbal Communication Skills.

· Motivated/Self Starter Individual capable of independent work with minimal oversight.

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