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Sr. Computer Systems Validation Analyst Katalyst Healthcares & Life Sciences - 4.0 Foster City, CA Job Details Contract 1 day ago Qualifications Quality control corrective actions Project team coordination GAMP Content creation for technical audiences Pharmaceutical regulatory compliance Preventive action implementation Technical writing experience within manufacturing Production deviation management Corrective and preventive actions (CAPA)

FDA 21 CFR

Part 11 Production validation processes Quality risk management Pharmaceutical company experience Quality assurance experience within pharmaceutical industry Software documentation Cross-functional communication Pharmaceutical manufacturing facility experience

Full 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.