Lead Validation Engineer

seeking an experienced Lead Validation Engineer to support a major SCADA and Environmental Monitoring System modernization project at a regulated manufacturing facility in Southern California.

This role will lead Computer System Validation (CSV), commissioning, qualification, and release activities for SCADA, PLC, environmental monitoring, virtual infrastructure, databases, historian interfaces, and manufacturing system integrations. The project will follow a Waterfall SDLC and risk-based validation approach within a GxP environment.

• Lead validation activities for SCADA, PLC, and Environmental Monitoring System upgrades.
• Develop and execute validation documentation, including Validation Plans, URS, risk assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.
• Lead qualification of control systems, virtual infrastructure, servers, SQL databases, historian interfaces, and operator workstations.
• Develop and execute risk-based testing for alarms, audit trails, user access, data integrity, backup/recovery, and system interfaces.
• Support data migration, UAT, PQ, discrepancy resolution, and system release.
• Coordinate validation activities across Quality, Automation, Engineering, IT, Operations, and external vendors.
• Maintain project schedules and communicate validation status, risks, and issues to project leadership.

• Bachelor's degree in Engineering, Life Sciences, Computer Science, or related technical field.
• Strong validation experience within pharmaceutical, biotechnology, or other GxP-regulated manufacturing environments.
• Experience leading Computer System Validation or automation validation projects.
• Hands-on experience with IQ/OQ/PQ, risk assessments, requirements, traceability, deviations, and validation reporting.
• Experience validating SCADA, PLC, Environmental Monitoring, historian, database, or manufacturing control systems.
• Strong understanding of GxP, data integrity, audit trails, electronic records, and risk-based validation.
• Ability to work on-site in Southern California.
  
  Preferred Experience.

• GE Digital iFIX or similar SCADA platforms.
• Rockwell PLCs and industrial control systems.
• VMware, Windows Server, and SQL Server.
• Process historians and data migration.
• Kneat or similar electronic validation systems.
• Previous experience leading complex automation or computerized system validation projects.