Senior CSV Consultant
Katalyst Healthcares and Life Sciences, Portsmouth, NH, United States
Roles & Responsibilities:
Implement and validate computerized systems including PCS (DeltaV), Rockwell, MES (Syncade), SCADA, and PLC. uthor, 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
Implement and validate computerized systems including PCS (DeltaV), Rockwell, MES (Syncade), SCADA, and PLC. uthor, 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