Senior CSV Analyst: GxP Validation for SCADA & PLC Systems

Katalyst CRO; Foster City (CA); In loco; USD 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

Katalyst CRO in Foster City, CA is seeking a Senior CSV Analyst to lead validation activities for SCADA, PLC, Rockwell FactoryTalk and Ignition systems in a GxP environment. You will plan, execute, and document validation lifecycle activities, ensure regulatory compliance, and collaborate with cross-functional teams to maintain validated states.

Applicants should have 5+ years in CSV within Life Sciences, hands-on validation of SCADA/industrial controls, and strong expertise in GAMP 5, 21 CFR

Competenze

• 5+ years of experience in Computer Systems Validation (CSV) within Life Sciences/Pharma environments.
• 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.
• Excellent technical writing and documentation skills.

Mansioni

• 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.

Conoscenze

GxP knowledge

Technical writing

Project coordination

Regulatory compliance

Strumenti

SCADA

Rockwell FactoryTalk

Ignition

Descrizione del lavoro

Katalyst CRO in Foster City, CA is seeking a Senior CSV Analyst to lead validation activities for SCADA, PLC, Rockwell FactoryTalk and Ignition systems in a GxP environment. You will plan, execute, and document validation lifecycle activities, ensure regulatory compliance, and collaborate with cross-functional teams to maintain validated states.

Applicants should have 5+ years in CSV within Life Sciences, hands-on validation of SCADA/industrial controls, and strong expertise in GAMP 5, 21 CFR