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