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Validation Specialist

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Onsite

Validation Specialist

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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