K
Katalyst CRO
Senior CSV Consultant
Skills
Compliance
1 month ago
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Important information
Contract type:
Freelance / Contract
Location:
Gresham, OR, USA
Work mode:
Onsite
Published on:
12 September 2026
What they need
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.
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