Senior CSV Analyst: GxP Validation for SCADA/PLC

JobDiva, Inc.; Foster City (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

JobDiva, Inc. is seeking a Senior Computer Systems Validation (CSV) Analyst for GxP life sciences environments. You will plan, lead, and execute validation activities for SCADA, PLCs, Rockwell FactoryTalk, and Ignition systems, ensuring compliance with 21 CFR Part 11 and EU Annex 11.

The role requires hands-on validation lifecycle documentation, risk assessments, change controls, IQ/OQ/PQ, and collaboration with Engineering, QA, IT, and business teams to keep systems validated and compliant.

Qualifications

• 5+ years of CSV experience in Life Sciences/Pharma/biotech environments.
• Hands-on validation of SCADA/PLC/Rockwell FactoryTalk/Ignition systems.
• Strong knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11.

Responsibilities

• Plan, lead, and execute CSV activities for SCADA, PLC, Rockwell FactoryTalk, and Ignition systems.
• Develop and review URS, FS, DS, Validation Plans, Risk Assessments, Traceability Matrices, IQ/OQ/PQ protocols, and Summary Reports.
• Author and maintain documentation for GxP computerized systems and ensure compliance with regulatory requirements.
• Apply GAMP 5 principles throughout the CSV lifecycle and manage deviations, CAPAs, and validation discrepancies.
• Collaborate with Automation, Engineering, QA, IT, Manufacturing and business stakeholders to deliver validated systems on schedule.

Skills

Technical writing

Communication

Project coordination

Tools

SCADA

Rockwell FactoryTalk

Ignition

Job description

JobDiva, Inc. is seeking a Senior Computer Systems Validation (CSV) Analyst for GxP life sciences environments. You will plan, lead, and execute validation activities for SCADA, PLCs, Rockwell FactoryTalk, and Ignition systems, ensuring compliance with 21 CFR Part 11 and EU Annex 11.

The role requires hands-on validation lifecycle documentation, risk assessments, change controls, IQ/OQ/PQ, and collaboration with Engineering, QA, IT, and business teams to keep systems validated and compliant.