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Senior CQV Engineer
Senior CQV EngineerKatalyst Healthcares and Lifesciences • San Francisco, California, United States
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Senior CQV Engineer

Senior CQV Engineer

Katalyst Healthcares and Lifesciences • San Francisco, California, United States
[job_card.variable_days_ago]
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  • [job_card.full_time]
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Roles & Responsibilities

Lead smoke studies, including airflow visualization and identifying stagnant air or pass-through airflow issues.

Support pressurization challenge studies and evaluate what happens during loss of differential pressure.

Perform temperature mapping for rooms and process or small equipment.

Review vendor commissioning data for temperature, humidity, air exchanges, and HVAC-related inputs.

Review URS and vendor IOQ documentation and perform verification testing when needed.

Support electrical verification, P&ID walkdowns, and redline updates.

Support qualification of small equipment such as biosafety cabinets, sorbents, centrifuges, and other QC / process instruments (final QC list pending).

Determine what can be done internally versus through a vendor for smoke studies and other tests.

Document qualification results and compile required information.

Provide weekly updates, track basic scope / schedule / cost, and communicate effectively with the client and vendors.

Support with EMPQ.

Requirements

Must have real validation experience and the ability to lead the work independently.

Strong experience with facility qualification, smoke studies, temperature mapping, and verification of small equipment.

ble to think ahead, suggest additional helpful tests, and drive deliverables.

Must not require heavy management or handholding.

Strong communicator and organized.

8 years of experience.

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