CSV Engineer

Shop Floor CSV/CSA Lead/Engineer

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 and 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.