Senior Computer Systems Validation (CSV) Expert

Job Description

Job Title: Senior Computer Systems Validation Expert
Experience: 10+ Years
Domain: Life Sciences / Pharmaceutical / GxP

Must-Have Skills

• 10+ Years of CSV Experience
• 10+ Years of SAP System Validation
• GxP / GMP Regulated Environment
• CSV / SDLC Practices
• SAP S/4HANA / BTP / MDG
• Risk-Based Validation
• Change Control & Impact Assessment
• URS / Functional Requirements
• Validation Protocols & Test Execution
• Requirements Traceability Matrix (RTM)
• Data Migration Validation
• Validation Summary Reports
• Risk Assessments / DRA
• Deviation / Discrepancy Management
• Root Cause Analysis & CAPA
• Inspection-Ready Documentation

Required Experience

• Lead CSV activities for large-scale, cross-functional SAP initiatives.
• Develop and implement risk-based validation strategies.
• Lead validation risk assessments for system functionality and data flows.
• Ensure complete traceability from requirements through testing.
• Coordinate validation activities across Business, Digital, QA, QC, Infrastructure, and vendors.
• Review test execution and ensure objective validation evidence is properly documented.
• Investigate deviations, discrepancies, and anomalies and support CAPA/re-testing.
• Prepare and review key CSV deliverables and ensure compliance with GxP requirements.

Preferred

• Experience validating AI solutions in a GMP environment
• CSV leadership for Manufacturing and Supply Chain digital projects

Strong stakeholder management and communication skills