Key Responsibilities
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.
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.
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
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 settings.
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.
Solid 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