Sr. Computer Systems Validation Analyst

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

Summary :
We are seeking a Senior Computer Systems Validation (CSV) Analyst with strong experience in GxP-regulated pharmaceutical/life sciences environments. The candidate will be responsible for planning, leading, and executing validation activities for SCADA, Rockwell FactoryTalk, PLCs, and Ignition process control systems.
The role requires hands-on expertise in GAMP 5, 21 CFR Part 11, EU Annex 11, validation lifecycle documentation, risk assessments, change controls, and qualification protocols (IQ/OQ/PQ). The candidate will work closely with engineering, automation, quality, IT, and business teams to ensure systems remain compliant and validated.

Roles & 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.
• Apply GAMP 5 principles throughout the computer system validation lifecycle.
• Execute software/system validation test protocols and document results.
• Manage change controls for existing qualified systems.
• Assess system changes and determine validation impact.
• Prepare/revise validation documentation based on system changes.
• Ensure compliance with 21 CFR Part 11 and EU Annex 11.
• Manage deviations, issues, CAPAs, and validation discrepancies.
• Develop and execute test protocols and maintain proper evidence/documentation.
• Maintain project schedules and ensure validation deliverables are completed on time.
• Collaborate with Automation, Engineering, QA, IT, Manufacturing, and business stakeholders.

Education & Experience

• 5+ years of experience in Computer Systems Validation (CSV) within Life Sciences/Pharmaceutical/Biotech environments.
• Strong experience validating SCADA, PLC, Rockwell FactoryTalk, and/or Ignition systems.
• Hands-on experience with GAMP 5 and risk-based validation approaches.
• Strong knowledge of 21 CFR Part 11 and EU Annex 11.
• Experience with change control and system requalification.
• Experience managing deviations, issues, CAPAs, and corrective actions.
• Strong understanding of GxP computerized systems and regulated manufacturing environments.
• Excellent technical writing and documentation skills.
• Strong communication and project coordination skills.