Senior Product Owner - CSV
GSK (company site, opens in a new tab)2–4 yrsBengaluruOn-siteDirect career pageEst. 18–30 LPA
Posted 14h ago
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Job description
Structured overview of role & requirements
About This Role
- Lead and manage Computer System Validation (CSV) activities for Manufacturing Execution System (MES) platforms, ensuring systems meet GxP, data integrity, security, and regulatory compliance throughout their lifecycle.
- Own validation planning, risk assessments, testing, change control, and maintain audit-ready status with timely closure of audit findings and CAPAs.
- Drive continuous improvement, standardization, and adoption of AI-enabled and automated validation practices to enhance validation efficiency and compliance.
Minimum Requirements
- Bachelor’s or Master’s degree in Computer Science, IT, Engineering, Business, Life Sciences, or related field, or equivalent experience.
- 2–4 years of experience in CSV, validation, quality, business analysis, or technology delivery within regulated manufacturing environments, specifically with enterprise MES platforms.
- Proven experience managing CSV deliverables including Validation Plans, Risk Assessments, URS, FS, DS, Traceability Matrices, Test Protocols (IQ/OQ/PQ/UAT), Validation Reports, and Change Controls.
- Strong knowledge of GxP, data integrity, security, regulatory requirements and experience using AI and automation tools in validation activities.
Ideal Candidate Profile
- Experienced in collaborating cross-functionally with Quality, Validation, Engineering, IT, and business teams to deliver compliant, validated MES solutions.
- Capable of translating regulatory and business requirements into risk-based validation strategies aligned with product roadmaps and operational priorities.
- Skilled in driving audit readiness and compliance governance in a complex, regulated pharmaceutical manufacturing environment with focus on continuous improvement and automation.