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KH

Senior CSV Consultant

Katalyst Healthcares & Life Sciences
๐Ÿ‡บ๐Ÿ‡ธ United States
On-site
Senior
1 month ago
  • SCADA
  • PLC
  • DCS
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Roles & Responsibilities:
  • 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.

Senior CSV Consultant ยท Katalyst Healthcares & Life Sciences

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