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Sr. Validation Engineer

Sr. Validation Engineer

Katalyst HealthCares & Life SciencesCambridge, MA
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Job Description :

  • Support a multi-phase validation project involving the reconfiguration of manufacturing Suites & and implementation of Client production.

Responsibilities :

  • Equipment decommissioning and clean room updates.
  • Validation protocol generation, execution, and final certification.
  • Facility readiness and compliance documentation.
  • Summary reporting and archiving of validated materials.

    • Requirements :

  • Familiarity with cleanroom qualification and pharma equipment (Isolators, BSCs, skids).
  • Knowledge / experience working with DeltaV systems.
  • Strong grasp of change control and impact assessment procedures.
  • Capable of executing smoke studies, HEPA certifications, and cleaning validations.
  • Proven record managing documentation for audits and regulatory review.
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    Validation Engineer • Cambridge, MA