Sr. Computer Systems Validation Analyst

Foster City, CA

Instant Apply

30+ days ago

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.

Numbers & Facts

Location

Foster City, CA

Skills

Analysis Skillsunmatched
Automationunmatched
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Change Controlunmatched
Change Managementunmatched
Code of Federal Regulationsunmatched
Communication Skillsunmatched
Computer Skillsunmatched
Computer Systemsunmatched
Control Systemsunmatched
Corrective Actionunmatched
Documentationunmatched
Environmental Sciencesunmatched
GxPunmatched
Information Technology & Information Systemsunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Manufacturing Systemsunmatched
Organizational Skillsunmatched
Process Control Engineeringunmatched
Process Validationunmatched
Programmable Logic Controller (PLC)unmatched
Project Scheduleunmatched
Project/Program Coordinationunmatched
Quality Assuranceunmatched
Riskunmatched
Risk Analysisunmatched
Software Validationunmatched
Supervisory Control and Data Acquisition (SCADA)unmatched
System Lifecycleunmatched
System Testunmatched
System Validationunmatched
Systems Analysisunmatched
Technical Writingunmatched
Test Plan/Scheduleunmatched
Time Managementunmatched
Traceabilityunmatched
Validation Documentationunmatched
Validation Planunmatched
Validation Testingunmatched
Writing Skillsunmatched

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