Computerised System Validation (CSV) Projects Lead
Core
Lead Computerised System Validation (CSV) activities across multiple project teams to ensure compliance with global standards and GxP regulations in a regulated manufacturing environment.
Role type
Senior CSV Projects Lead
Builds
Compliant digital solutions for manufacturing sites (PLCs, SCADA, MES)
Domain
Animal Health Manufacturing / GxP Regulated Industry
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Computerised System Validation (CSV), GxP regulations, validation of manufacturing and IT systems, change control management, project planning and design, stakeholder management, process improvement
Preferred skills
Digital tools for validation, MES/SCADA/PLC experience
Technologies
PLCs, SCADA systems, historians, MES platforms
Responsibilities
Drive standardization and adherence to CSV methodologies, lead validation planning and design, provide oversight and coaching to CSV analysts, ensure quality oversight of change control and validation activities, collaborate with IT/Quality/Manufacturing teams, support continuous improvement of CSV processes
Seniority
Senior, hands-on IC with leadership
