GxP Validation Lead

Key Responsibilities

1. OT GxP Validation

• Lead GxP validation efforts for changes impacting OT systems, applications, and infrastructure.
• Carry out and/or review GxP impact and risk assessments for proposed OT modifications.
• Establish the appropriate risk-based validation strategy according to system criticality and GxP impact.
• Confirm that validation obligations are built into OT remediation, migration, and cutover plans.

2. Validation Documentation & Execution

• Prepare, review, and maintain validation documentation in alignment with Client-approved SOPs and templates.
• Create and/or review IQ and OQ protocols, test scripts, and supporting evidence.
• Coordinate the execution of qualification/validation testing during OT infrastructure and application changes.

3. OT Infrastructure & Application Changes

Provide validation oversight for GxP-relevant changes across areas such as:

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

4. Migration & Cutover Validation

• Review migration and cutover plans from a GxP validation standpoint.
• Ensure the required validation activities are included in migration runbooks.
• Verify that required IQ/OQ execution and interface testing are completed.

Required Skills & Experience

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

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