Jobs · Quality Assurance · New Jersey

Validation Specialist

Katalyst CRO · Newark, NJ · 1 mo ago
On-siteQuality AssuranceContract

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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