CSV Lead

Roles & Responsibilities:

• 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.

Required Qualifications:

• 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.