Validation Specialist

Katalyst Healthcares and Life Sciences

Denver, CO

Roles & Responsibilities:

Support cleaning validation activities, protocol execution, sampling, and documentation.
Perform temperature mapping and requalification of controlled temperature units.
Execute IQ/OQ/PQ, requalification, and periodic review for GMP equipment and utilities.
Support commissioning, installation, and qualification of new or modified equipment.
ssist with equipment troubleshooting alongside Engineering and Operations.
Generate validation documentation following cGMP, GDP, and SOP requirements.
Support validation lifecycle activities, change controls, investigations, and CAPAs.
Participate in audit readiness and regulatory inspection support.
Bachelor's degree in Engineering, Life Sciences, or related discipline required.
5+ years of hands-on validation experience with GMP equipment and utilities.

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Vacancy posted 1 day ago

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