Role Title
Computer System Validation (CSV) Lead
Location
Hybrid / Remote with occasional travel to manufacturing sites as required
Flexibility to support global teams and multiple time zones is preferred.
Role Summary
We are seeking an experienced Computer System Validation (CSV) Lead to support a large-
scale global life sciences manufacturing technology transformation program. The role will
focus on ensuring that infrastructure, operational technology, and shopfloor-related systems are
implemented, migrated, and operated in compliance with applicable GxP, CSV, SDLC, data
integrity, and quality requirements.
The CSV Lead will work closely with cross-functional teams including Quality, IT, OT,
Cybersecurity, Infrastructure Engineering, Site Deployment, and Program Management teams to
ensure validation activities are risk-based, compliant, timely, and audit-ready.
Key Responsibilities
 Lead CSV strategy, planning, and execution for regulated manufacturing technology and
infrastructure transformation initiatives.




 Define and manage validation deliverables including validation plans, risk assessments,
requirements, traceability matrices, test protocols, test evidence, summary reports,
SOPs, and operational handover documentation.
 Partner with Quality and business stakeholders to assess GxP impact, validation scope,
change control requirements, and documentation expectations.
 Ensure infrastructure and platform changes are executed in alignment with approved
SDLC, CSV, GMP, and data integrity procedures.
 Support validation activities for systems and platforms related to OT infrastructure,
identity management, access control, endpoint management, monitoring, and shopfloor
application integration.
 Coordinate validation activities across global manufacturing sites, ensuring consistency
while accommodating site-specific requirements and local quality processes.
 Review technical design, configuration, migration, and testing documentation to ensure
compliance read

📌 CSV Lead (India)
🏢 Cognizant
📍 India