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 readiness and audit defensibility.

 Support site deployment teams during readiness assessments, cutover planning,

migration execution, hypercare, and transition to steady-state operations.

 Identify validation risks early and drive mitigation plans in collaboration with Quality, IT,

OT, Cybersecurity, and Program leadership.

 Ensure all validation evidence is complete, accurate, review-ready, and aligned with applicable regulatory expectations.

 Participate in governance forums, change reviews, risk reviews, and site readiness discussions as the CSV subject matter expert.

Required Experience

 10+ years of experience in Computer System Validation / Computer Software

Assurance / Quality Compliance within the life sciences industry.

 Robust experience working in GxP-regulated manufacturing environments, preferably pharmaceutical, biotechnology, medical devices, or other regulated manufacturing sectors.

 Hands-on experience with validation of infrastructure, IT/OT platforms, shopfloor systems, manufacturing applications, or related technology programs.

 Strong understanding of CSV lifecycle deliverables including URS/FRS, risk assessment,

validation plan, IQ/OQ/PQ, test scripts, traceability matrix, deviation management, and validation summary report.

 Experience supporting technology changes in live manufacturing or production environments where downtime, compliance, and product quality are critical considerations.

 Familiarity with change control, incident management, problem management,



SOP governance, and audit readiness in regulated environments.

 Experience working with global delivery teams, site teams, Quality organizations, and technical SMEs across multiple geographies.

Preferred Experience

 Exposure to manufacturing OT environments and systems such as MES, DCS,

historians, lab systems, building automation systems, or related shopfloor platforms.

 Experience validating infrastructure components such as Active Directory, PKI/certificate management, privileged access management, endpoint management, patching tools,

monitoring platforms, or cybersecurity controls.

 Familiarity with standards and expectations such as:

o 21 CFR Part 11

o EU Annex 11

o GAMP 5

o ALCOA+ data integrity principles o GMP change control o SDLC / CSA approaches

 Experience working on global site rollout, system migration, infrastructure modernization,

or IT/OT transformation programs.

 Experience with ServiceNow or similar tools for change, incident, problem, request, and configuration management.

Education

 Bachelor’s degree in Engineering, Life Sciences, Computer Science, Information

Technology, Pharmacy, or related discipline.

 Advanced degree or certifications in CSV, Quality, GAMP, ITIL, or regulated systems validation are preferred.

Success Measures The successful candidate will be expected to:

 Deliver an approved CSV strategy for a global OT infrastructure and manufacturing systems transformation program.

 Ensure program-level SDLC documentation is completed, reviewed, and approved on time.

 Establish validation strategies for infrastructure products and GMP application migration activities.

 Provide timely validation guidance and sign-off support for each manufacturing site entering deployment.

 Ensure all validation deliverables are complete, compliant, traceable, and audit-ready.

📌 CSV Lead (India)
🏢 Cognizant
📍 India