Key Responsibilities

1. OT GxP Validation

- Lead GxP validation activities associated with changes to OT systems, applications and infrastructure.
- Perform/review GxP impact and risk assessments for proposed OT changes.
- Define the appropriate risk-based validation approach based on system criticality and GxP impact.
- Ensure validation requirements are incorporated into OT remediation, migration and cutover plans.

2. Validation Documentation & Execution

- Prepare, review and update validation documentation using Client approved SOPs and templates.
- Develop/review IQ and OQ protocols, test scripts and associated evidence.
- Coordinate execution of qualification/validation tests during OT infrastructure and application changes.

3. OT Infrastructure & Application Changes

Provide validation oversight for GxP-impacting changes involving areas such as:

- OT application servers and virtual machines
- OT network and infrastructure changes
- OT Active Directory/domain-related changes
- Application interfaces and integrations

4. Migration & Cutover Validation

- Review migration and cutover plans from a GxP validation perspective.




- Ensure required validation activities are included within migration runbooks.
- Verify execution of required IQ/OQ and interface testing.

Required Skills & Experience

- Strong experience in GxP validation / Computer System Validation (CSV) within regulated manufacturing environments.
- Experience validating Operational Technology (OT) systems and infrastructure.
- Robust understanding of GAMP 5 and risk-based validation principles.
- Good understanding of manufacturing OT architecture and IT/OT dependencies.
- Ability to work with QA, Engineering, IT/OT, infrastructure, cybersecurity, application SMEs and OEM/vendor teams.
- Strong documentation, stakeholder-management and communication skills.

Preferred OT Knowledge

For this position, I would specifically look for candidates who have worked around technologies such as:

- SCADA / HMI
- MES / manufacturing applications
- PLC/DCS-connected applications
- OPC / industrial communication interfaces
- Industrial networks and firewalls
- OT Active Directory

📌 GxP Validation Lead (Tamil Nadu)
🏢 Cognizant
📍 Tamil Nadu