Senior CSV Consultant

JobDiva, Inc.; Gresham (OR); Sur place; USD 95 000 - 130 000; Plein temps

Résumé du poste

Creative Solutions Services, LLC in Oregon is seeking a seasoned CSV professional to implement and validate computerized systems including DeltaV PCS, Rockwell, MES Syncade, SCADA, and PLCs.

You will author and execute CSV lifecycle documents, manage CSV projects, coordinate teams, monitor KPIs, and ensure compliance with 21 CFR Part 11 and Annex 11. On-site work in Gresham is expected.

Qualifications

• Implement and validate computerized systems including DeltaV, Rockwell, MES Syncade, SCADA and PLC.
• Author, review, approve, and execute CSV lifecycle documentation.
• Manage CSV projects with coordination, scheduling, reporting and KPIs.

Responsabilités

• 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.

Connaissances

CSV lifecycle management

Regulatory compliance

Project coordination

Outils

DeltaV

Rockwell

MES Syncade

SCADA

PLC

Description du poste

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.