CSV Engineer - Endosafe Automation

Smartedge Client is looking for an individual to help with their CSV Engineer - Endosafe Automation @ Remote Role Summary: We are looking for an experienced Computerized System Validation (CSV) Engineer to support the validation of an automated Endosafe production line and its integration with site systems. The role involves working with equipment vendors, QA, Automation, and IT teams to ensure compliance with FDA and GxP requirements throughout the project lifecycle. Key ResponsibilitiesExecute CSV activities for automated equipment and associated software.Validate integrations with MES, Power BI, and other site systems.Work with vendors to understand automation software capabilities and functionality.Develop and review validation documentation (URS, Risk Assessments, IQ/OQ/PQ, Validation Reports).Coordinate validation activities with the Charleston, SC QA team.Support deviations, change controls, CAPAs, and post-launch issues.Ensure systems remain compliant and in a validated state.Required Skills & Experience5+ years of Computerized System Validation (CSV) experience in Life Sciences/Pharma.Strong knowledge of: FDA 21 CFR Part 11GAMP 5FDA CSV requirementsData Integrity (ALCOA+)Experience with automation systems, equipment validation, and system integrations.Exposure to MES, Power BI, PLC/HMI, or manufacturing automation platforms.Excellent stakeholder management and vendor coordination skills. If this sounds like a role you would be interested in or if you know someone in this field. Connect with me or email me at vineetha.s@smartedgesolutions.co.uk Alternatively, you can call me on Tel: +44(0)203 500 2108.