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Katalyst CRO

Senior CSV Consultant

Katalyst CRO, Portsmouth, New Hampshire, United States, 00215

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Senior CSV Consultant

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Katalyst CRO We are seeking a

Senior CSV Consultant

to implement and validate computerized systems, author and execute Computer System Validation (CSV) lifecycle documentation, and manage CSV projects. Implement and validate computerized systems including PCS (DeltaV), Rockwell, MES (Syncade), SCADA, and PLC. Author, review, approve, and execute Computer System Validation (CSV) lifecycle documentation. Manage CSV projects, including team coordination, scheduling, reporting, and KPIs. Perform change assessments for DCS (DeltaV) and MES (Syncade) systems. Support commissioning and qualification of DCS software, particularly DeltaV. Ensure compliance with regulatory standards like 21 CFR Part 11 and Annex 11. Collaborate effectively in both independent and team-oriented work environments. Job Details

Seniority level: Associate Employment type: Contract Job function: Consulting, Information Technology, and Sales Industry: Pharmaceutical Manufacturing

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