Sr. Computer Systems Validation Analyst

Katalyst-Healthcares-; Foster City (CA); Sur place; USD 120 000 - 180 000; Plein temps

Résumé du poste

Creative Solutions Services, LLC is seeking a Senior CSV Analyst to lead validation activities for SCADA, PLC, Rockwell FactoryTalk, and Ignition systems in a GxP regulated environment.

The role requires hands-on expertise in GAMP 5, 21 CFR Part 11, EU Annex 11, and risk-based validation approaches, with strong technical writing and cross-functional collaboration skills.

Qualifications

• 5+ years of experience in Computer Systems Validation (CSV) within Life Sciences/Pharma/Biotech.
• 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.

Responsabilités

• 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.

Connaissances

CSV in Life Sciences

GxP Compliance

GAMP 5

Risk-based Validation

Technical Writing

Cross-functional Collaboration

Formation

Bachelor's degree in Life Sciences / Engineering

Outils

Rockwell FactoryTalk

Ignition

SCADA

Description du poste

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.