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Katalyst Healthcares & Life Sciences
Validation Specialist
1 month ago
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Important information
Contract type:
Freelance / Contract
Location:
Newark, NJ, USA
Work mode:
Onsite
Published on:
14 September 2026
What they need
Job summary:
We are seeking an experienced Validation Specialist to support validation activities in a GMP-regulated environment.
Roles and Responsibilities:
- 10 years of experience in Validation within Pharma, Biotech, or Life Sciences.
- Hands-on experience with IQ, OQ, and PQ.
- Experience with equipment, facility, utility, or process validation.
- Strong knowledge of GMP, GxP, and FDA regulations.
- Experience developing and executing validation protocols and reports.
- Experience with deviations, CAPA, change controls, and risk assessments.
- Experience supporting FAT/SAT, commissioning, and qualification activities.
- Strong technical writing and documentation skills.
- Ability to work with Engineering, Quality, Manufacturing, and Validation teams.
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