GxP Validation Lead

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.
• 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