Sr. Computer Systems Validation Analyst
Katalyst Healthcares & Life SciencesFoster City, CA
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Overview
Remote
On-site
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.
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FAQs About Sr. Computer Systems Validation Analyst Jobs at Katalyst Healthcares & Life Sciences
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This job at Katalyst Healthcares & Life Sciences is located in Foster City, CA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Katalyst Healthcares & Life Sciences?
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