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 strong 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

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 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.

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.

- Positive 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