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Sr. Validation Engineer
Sr. Validation EngineerKatalyst Healthcares and Life Sciences • Cambridge, MA, United States
Sr. Validation Engineer

Sr. Validation Engineer

Katalyst Healthcares and Life Sciences • Cambridge, MA, United States
2 days ago
Job type
  • Full-time
Job description

Job Description :

  • Support a multi-phase validation project involving the reconfiguration of manufacturing Suites 5 & 6 and implementation of Client production. Responsibilities include.
  • 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, United States

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