KH
Senior CSV Consultant
Katalyst Healthcares & Life Sciences
- 🇺🇸 United States
- On-site
- Senior
- 2 months ago
- SCADA
- PLC
- DCS
2 months ago
- 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 · Katalyst Healthcares & Life Sciences