CSV Lead

The CSV Lead is responsible for leading Computer System Validation activities for GxP-regulated systems within pharmaceutical, biotechnology, or healthcare environments. The role oversees validation strategy, planning, execution, and documentation while ensuring compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, and applicable FDA/GxP requirements. The position works closely with IT, Quality, Business, and cross-functional teams to maintain validated systems and ensure inspection readiness.

• 10+ years of experience in CSV / Computer System Validation within Pharma, Biotech, Medical Device, or Life Sciences.
• Strong knowledge of GxP validation lifecycle and risk-based validation approaches.
• Hands-on experience with URS, FS/DS, IQ/OQ/PQ, UAT, RTM, and validation reports.
• Strong knowledge of 21 CFR Part 11, GAMP5, FDA, and data integrity requirements.
• Experience with deviations, CAPA, change control, and risk assessments.
• Strong technical documentation and project leadership skills.
• Experience working with cross-functional teams in regulated environments
• Experience with laboratory systems such as LIMS, CDS, ELN, or SDMS.
• Experience with manufacturing systems, MES, ERP, or automation-related systems.
• Experience with systems such as LabWare, Empower, TrackWise, Veeva, or SAP.
• Experience with data integrity assessments and audit/inspection support.
• Experience leading CSV teams and managing multiple validation projects.
• Bachelor's degree required in Computer Science, Information Technology, Engineering, Life Sciences, Pharmacy, or a related technical/scientific discipline.
• Lead and manage Computer System Validation (CSV) activities across regulated Life Sciences projects.
• Develop and review validation plans, protocols, test scripts, reports, and validation documentation.
• Lead validation lifecycle activities including URS, FS/DS, IQ, OQ, PQ, UAT, and RTM.
• Perform risk assessments and ensure systems are validated in compliance with GxP requirements.
• Support validation of GxP computerized systems, laboratory systems, manufacturing systems, and enterprise applications.
• Manage deviations, CAPA, change controls, and validation-related investigations.
• Provide technical leadership and coordinate with QA, IT, Engineering, Manufacturing, and Business teams.
• Ensure compliance with FDA regulations, 21 CFR Part 11, GAMP5, and data integrity requirements.
• Support audits, inspections, and inspection-readiness activities.
• Manage project timelines, deliverables, and validation documentation.