Validation Specialist
Job in
Framingham, Middlesex County, Massachusetts, 01701, USA
Listed on 2026-07-04
Listing for:
Katalyst Healthcares & Life Sciences
Full Time
position Listed on 2026-07-04
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Job Description & How to Apply Below
Summary :
- 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.
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