CSV Engineer

Job Summary: Shop Floor CSV/CSA Lead/Engineer responsible for leading and executing validation deliverables across the lifecycle in regulated manufacturing and laboratory GMP/GLP environments. The role includes automation/controls validation, risk-based validation activities, audit readiness, data integrity compliance, and coordination with IT/OT teams for validated systems. Roles & Responsibilities: Lead and execute validation deliverables including risk assessment, validation planning, requirements traceability, test strategy, test execution, deviation management, and final reporting/release. Apply a risk-based approach (GxP impact, patient/product risk, data integrity) to define validation scope and testing depth. Author and review validation documentation including Compliance Plan/Test Protocols, Risk Assessments, Requirements and Traceability Matrix (RTM), test scripts, test summaries, and compliance reports. Validate PLC logic changes including configuration, recipes, alarms, interlocks, and permissives. Validate SCADA/HMI functions including screens, alarms, trends, historian interfaces, user roles, and electronic records. Support MES/PLC/SCADA/ERP interface validation activities. Ensure data integrity controls for automation data including audit trails, access controls, backups/restore, record retention, time synchronization, and change control. Support audits and inspections by providing validation documentation and evidence of control effectiveness. Review and approve vendor documentation including FAT/SAT and integrate into validation packages. Participate in deviation investigations, root cause analysis, and CAPA activities related to validated systems. Coordinate with IT/OT teams on system hardening, patching strategies, backups, access management, and network segmentation impacts to validated systems. Validate interfaces including PLC–SCADA, historian, MES, and LIMS controlled data flows. Work with technologies including Siemens, Rockwell/Allen-Bradley, Schneider, ABB PLCs, Ignition, Wonderware/AVEVA, FactoryTalk View, WinCC, iFIX, OSIsoft PI, OPC/OPC UA, and SQL-based integrations. Experience: Experience in automation/controls and validation/qualification within regulated or quality-managed environments. Hands-on understanding of PLC/SCADA architectures, control strategies, alarms, and HMI design concepts. Strong documentation skills with ability to produce audit-ready validation evidence. Working knowledge of change control, deviation handling, and risk management. Experience with GxP environments and computerized system validation (CSV) / computer software assurance (CSA) approaches. Familiarity with electronic records/e-signatures expectations and data integrity principles. Experience with commissioning and FAT/SAT testing. Able to work in Manufacturing and Laboratory GMP/GLP facilities at client site.