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Validation Engineer

Katalyst CRO

3.7
51 reviews
Katalyst CRO
Job Type   /   Job Level
Contract   /   Senior Executive
Job Location
Houston, TX
Salary Range
USD 6,667 - USD 9,167 (Monthly)
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Summary

We are looking for a Validation Engineer II with experience in the pharmaceutical or biopharmaceutical industry to join our growing team.

Roles & Responsibilities

  • Develop and execute IQ, OQ, PQ validation protocols and reports for equipment, utilities, and facilities.
  • Perform CQV activities, including Temperature Mapping for Controlled Temperature Units (CTUs).
  • Collaborate with Manufacturing, QA, Engineering, and R&D teams.
  • Analyze validation data, investigate deviations, and support CAPA implementation.
  • Prepare validation reports and support internal/external audits.
  • Review and support change controls for validated systems.

Education &Experience

  • Bachelor's degree in Engineering (Chemical, Biomedical, Mechanical, or related discipline).
  • 26 years of validation experience in the pharmaceutical or biopharmaceutical industry.
  • Strong knowledge of cGMP, FDA regulations (21 CFR Parts 210, 211 & 820), and ICH guidelines.
  • Hands-on experience with IQ/OQ/PQ and Temperature Mapping of Controlled Temperature Units is required.
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