Position Details:

- Location: Remote/India
- Employment Type: Contractual
- Years of Experience: 7+

Role Summary The GxP Validation Lead – OT will lead validation and compliance activities for Operational Technology (OT) infrastructure and applications within the Reckitt Digital Manufacturing Backbone (DMB) program.

The role requires a robust combination of GxP/CSV knowledge and practical understanding of manufacturing OT environments, particularly where changes involve OT applications, servers/VMs, industrial networks, interfaces and supporting infrastructure.

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.

2. Validation Documentation & Execution
- Prepare, review and update validation documentation using Reckitt-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

📌 GxP Validation Lead (India)
🏢 TESTQ Technologies
📍 India