Sr. Computer Systems Validation Analyst
Katalyst CRO • Foster City, California, United States
**Role & seniority: ** Senior Computer Systems Validation (CSV) Analyst (GxP / life sciences)
**Stack/tools: ** SCADA; Rockwell FactoryTalk; PLCs; Rockwell products; Ignition (process control); GxP computerized system validation documentation (URS/FS/DS, IQ/OQ/PQ, traceability matrices).
**Top 3 responsibilities: **
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Plan/lead/execute CSV for SCADA, PLC, Rockwell FactoryTalk, and Ignition systems.
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Author/review validation deliverables (URS/FS/DS, Validation Plans, risk assessments, traceability matrices, IQ/OQ/PQ protocols, Summary Reports).
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Manage compliance and governance activities: change control impact assessments, deviations/issues, CAPAs, and system requalification.
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Must-have skills:
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5+ years CSV experience in pharmaceutical/biotech (GxP).
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Strong knowledge of GAMP 5, 21 CFR Part 11, and EU Annex 11.
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Hands-on validation experience with SCADA/PLC/FactoryTalk/Ignition.
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Risk-based validation, qualification lifecycle (IQ/OQ/PQ), and traceability.
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Strong technical writing, documentation control, and test protocol execution.
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Nice-to-haves:
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Experience with broader computerized systems beyond process control; deeper Rockwell/Ignition implementation specifics.
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Demonstrated project scheduling/validation deliverable management across multiple stakeholders.
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Location & work type: Not specified in provided text.
Full 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.
