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Validation Specialist (CQV)

Company

Katalyst HealthCares & Life Sciences

Location

Los Angeles, United States

Type

Full-time


Job Description:
  • We're seeking a CQV Validation Specialist to perform commissioning, qualification, and validation (CQV) of process equipment, utilities, and facilities for a regulated pharmaceutical manufacturing site.

  • The ideal candidate will have hands-on experience with IQ/OQ/PQ, cleaning validation, and temperature mapping in GMP environments.
  • Responsibilities:
  • Execute and author IQ/OQ/PQ protocols for equipment, utilities, and facilities per the Validation Master Plan (VMP).

  • Perform temperature mapping for controlled areas, storage units, and process systems.

  • Support cleaning validation—develop MACO calculations, perform swab/rinse sampling, and review analytical results.

  • Lead and review validation documentation including protocols, reports, and risk assessments.

  • Collaborate with Engineering, QA, and Manufacturing during commissioning and qualification activities.

  • ...

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