GxP Validation Lead

Location: Chennai, India

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.

1. 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.

1. 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

1. 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.
+ Strong 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
Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.