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Urgent! GMP Tester / Validation Engineer Job Opening In Vacaville – Now Hiring Katalyst HealthCares & Life Sciences

GMP Tester / Validation Engineer



Job description


Job Description:

  • We are seeking a skilled GMP Tester / Validation Engineer with strong experience in testing and validating applications in regulated environments (GMP, GxP, Pharma, Life Sciences).


  • The ideal candidate will have hands-on expertise in validation testing, documentation, and compliance for critical applications such as MES, LIMS, ArchestrA, and manufacturing systems.


  • This role requires a detail-oriented professional who can design and execute validation tests, review traceability matrices, ensure regulatory compliance, and collaborate with cross-functional teams in a pharmaceutical manufacturing environment.

  • Responsibilities:
  • Design, develop, and execute validation test scripts (IQ, OQ, PQ, UAT) for GMP-regulated applications.


  • Perform traceability matrix review to ensure all functional requirements are covered and validated.


  • Conduct validation and compliance testing for pharma applications (MES, LIMS, ArchestrA, DCS, Veeva, InBatch, etc.).


  • Assess system interactions across development, validation, and production environments.


  • Ensure adherence to Good Manufacturing Practices (GMP) and Computer System Validation (CSV) guidelines.


  • Document test cases, test results, and deviations as per regulatory requirements.


  • Perform root cause analysis of failures and implement corrective and preventive actions (CAPA).


  • Support defect management, bug fixes, and enhancements in validated environments.


  • Collaborate with cross-functional teams including QA, IT, and manufacturing operations.


  • Provide support during audits and inspections by ensuring complete and compliant validation documentation.

  • Requirements:
  • Bachelor's or master's degree in computer science, Engineering, Life Sciences, or related field.


  • + years of experience in validation testing in GMP-regulated environments (Pharma, Biotech, Life Sciences).



  • Required Skill Profession

    Engineers



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