CSV Engineer

Computer System Validation – Project Lifecycle Execution

• Execute end-to-end CSV activities for new implementations, upgrades, integrations, and decommissioning projects.
• Perform validation for Manufacturing Systems, including:MES (Manufacturing Execution Systems)DCS / PLC / SCADA systemsSerialization systemsHistorian systemsEMS (Environmental Monitoring Systems)
• Perform validation for Laboratory Systems, including:LIMSCDSSDMSeLN
• Support Engineering and Utility Systems, including:Building Management Systems (BMS)Utilities monitoring and automation systemsAsset and equipment control systems

Validation Planning & Documentation

• Develop, execute, and review validation deliverables, including:Validation Plans / Validation Master Plans (VMP)User Requirements Specifications (URS)Functional & Configuration Specifications (FS/CS)Risk Assessments (GAMP 5, CSA-based)IQ, OQ, PQ protocols and reportsTraceability Matrices (RTM)
• Ensure validation documentation aligns with system criticality, intended use, and risk classification.