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Katalyst Healthcares and Life Sciences
Validation Specialist (CQV)Katalyst Healthcares and Life Sciences • Los Angeles, CA, United States
Validation Specialist (CQV)

Validation Specialist (CQV)

Katalyst Healthcares and Life Sciences • Los Angeles, CA, United States
2 days ago
Job type
  • Full-time
Job description
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.
  • Support change controls, deviations, and CAPA related to validated systems.
  • Participate in validation reviews and contribute to continuous improvement of site validation practices.
Requirements:
  • Bachelor's degree in engineering, Biotechnology, Life Sciences, or related field.
  • 3-6 years of CQV experience within pharmaceutical or biotech manufacturing.
  • Strong understanding of GMP, FDA guidelines.
  • Hands-on experience in equipment and cleaning validation, including utilities such as WFI, clean steam, and HVAC.
  • Proficiency in temperature mapping tools (e.g., Kaye Validator or equivalent) preferred.
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Validation Specialist (CQV) • Los Angeles, CA, United States

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