Job Overview
Company
Katalyst Healthcares & Life Sciences
Location
Cambridge, Massachusetts
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Job Description
Job Description:
- Support a multi-phase validation project involving the reconfiguration of manufacturing Suites 5 & 6 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.
About Katalyst Healthcares & Life Sciences
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Katalyst Healthcares & Life Sciences is actively hiring for this Sr. Validation Engineer position
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