Sr. Validation EngineerKatalyst Healthcares and Life Sciences • Cambridge, MA, United States
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Sr. Validation Engineer
Katalyst Healthcares and Life Sciences • Cambridge, MA, United States
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job_description.job_card.job_descriptionFamiliarity 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.
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 :
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Validation Engineer • Cambridge, MA, United States
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