Senior CSV Consultant

Creative Solutions Services, LLC; Gresham (OR); On-site; USD 95,000 - 130,000; Full time

Job summary

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.

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.

Skills

CSV lifecycle management

Regulatory compliance

Project coordination

Tools

DeltaV

Rockwell

MES Syncade

SCADA

PLC

Job description

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.