Validation Specialist
Job in
Denver, Denver County, Colorado, 80285, USA
Listed on 2026-11-04
Listing for:
Katalyst CRO
Full Time
position Listed on 2026-11-04
Job specializations:
-
Quality Assurance - QA/QC
Job Description & How to Apply Below
- 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.
- Assist 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.
This role, Validation Specialist at Katalyst CRO, could be your next career step.
This posting is for the Validation Specialist role at Katalyst CRO, based in Denver, CO, United States.
We are looking to fill the Validation Specialist position at Katalyst CRO in Denver, CO, United States.
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