Title: Validation Engineer

Location: Hyderabad

Exp: 3-4 Years

Job Description:
Key Responsibilities
- Plan, author, review, and execute CSV activities for GxP-regulated serialization and Track & Trace systems.
- Perform validation activities for TraceLink or equivalent serialization applications, interfaces, and integrations.
- Prepare, review, and maintain validation lifecycle documentation, including:
- Validation Plans
- User Requirements Specifications (URS)
- Functional and Design Specifications
- GxP and system risk assessments
- IQ/OQ/PQ protocols
- Test scripts and objective test evidence
- Requirements Traceability Matrices (RTM)
- Validation Summary Reports
- Execute functional, integration, regression, and end-to-end validation testing.
- Validate serialization processes including serial number management, commissioning, aggregation, partner onboarding, EPCIS data exchange, regulatory reporting, and exception handling.
- Apply risk-based validation methodologies and maintain traceability between requirements, risks, test cases, defects,



and validation evidence.
- Document and investigate validation deviations, test failures, defects, and discrepancies, and support timely resolution.
- Support system upgrades, patches, enhancements, integrations, and other changes through established change-control and validation processes.
- Maintain validation documentation in an inspection-ready state.
- Support internal audits, external audits, and regulatory inspections.

Serialization & Track & Trace Responsibilities
- Work with pharmaceutical serialization and Track & Trace platforms, preferably TraceLink.
- Support partner onboarding and end-to-end testing across serialization networks and external partners.
- Validate integrations between serialization platforms, packaging sites, 3PLs, CMOs, MAHs, and supply-chain partners.
- Validate serial number provisioning, pools, ranges, and related CMO/MAH processes.
- Validate serialization events including commissionin

📌 Validation Engineer (Hyderabad)
🏢 NR Consulting
📍 Hyderabad