Role Description

Validation Engineer - Serialization (TraceLink) Position Validation Engineer - Serialization (TraceLink) Location Hyderabad, India Work Model Work from Office (WFO) – 5 Days Industry Pharmaceutical / Life Sciences Experience 5+ years Timings 2 PM – 11 PM IST Role Summary We are seeking an experienced Validation Engineer with expertise in pharmaceutical Serialization and Track &

- Trace solutions, preferably the TraceLink platform, and at least 5 years of Computer System Validation (CSV) experience in the pharmaceutical or life-sciences industry. The role requires practical knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, GxP computerized-system validation, and data integrity. The successful candidate should understand serialization processes, partner onboarding, system integrations, serial number management, EPCIS data exchange, regulatory reporting, and global Track &
- Trace requirements. 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 related integrations.
- Develop, review, and maintain validation lifecycle documentation, including the following:
- Validation Plans
- User Requirements Specifications (URS)
- Functional and Design Specifications
- GxP and system risk assessments
- Installation Qualification, Operational Qualification, and Performance Qualification (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 for serialization systems and interfaces.
- Validate serialization processes including serial number management, commissioning, aggregation, EPCIS data exchange, partner onboarding, regulatory reporting, and exception handling.




- Apply risk-based validation and maintain traceability among requirements, risks, test cases, defects, and validation evidence.
- Document and investigate validation deviations, test failures, defects, and discrepancies, and support their timely resolution.
- Support system changes, upgrades, patches, enhancements, and integrations through established change-control and validation processes.
- Maintain validation documentation in an inspection-ready state and support internal audits, external audits, and regulatory inspections.
- Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, GxP, data-integrity requirements, and electronic-record/electronic-signature controls. Serialization and TraceLink Competencies
- Platform experience: Hands-on experience with pharmaceutical serialization solutions
- TraceLink experience is strongly preferred.
- Partner onboarding: Experience supporting onboarding and end-to-end testing across serialization networks and external partners.
- Integration landscape: Experience validating data exchange between enterprise serialization platforms, packaging sites, 3PLs, CMOs or contract manufacturers, Marketing Authorization Holders (MAHs), and other supply-chain partners.
- Serial number management: Knowledge of serial number provisioning to packaging lines, pools and ranges, and CMO/MAH-related processes.
- Serialization events: Understanding of commissioning, decommissioning, aggregation, disaggregation, packing, unpacking, shipping, receiving, and related events.
- EPCIS and troubleshooting: Ability to investigate interface failures, transaction errors, EPCIS issues,



and data discrepancies.
- Global requirements: Working knowledge of pharmaceutical serialization requirements across markets such as the United States, European Union, China, and Canada.

Mandatory

Qualifications

- Five years of relevant CSV experience in the pharmaceutical, biotechnology, or regulated life-sciences industry.
- Hands-on experience with serialization or Track &

- Trace systems, with TraceLink exposure.
- Robust practical knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, GxP computerized-system lifecycle management, and data integrity.
- Experience creating, reviewing, and executing validation documentation and risk-based test protocols.
- Experience with requirements traceability, test evidence, validation deviations, defects, and change controls.
- Strong documentation, analytical, troubleshooting, and stakeholder-communication skills.

Preferred Serialization

Experience

- Experience with Serialization / Track &

- Trace systems.
- Hands-on TraceLink configuration, validation, partner onboarding, or end-to-end integration testing.
- Experience with SAP ICH/ASN processes, EPCIS transactions, and message analysis.
- Knowledge of GS1 serialization standards and packaging-line integration.
- Experience with global serialization regulatory reporting.
- Experience supporting serialization or Track &
- Trace implementations, upgrades, migrations, or enhancements. Tools, Processes, and Collaboration
- Experience using ServiceNow for RITMs or service requests, incident management, and change requests or change control.
- Experience supporting deviations, Corrective and Preventive Actions (CAPAs), change controls, and production issues in a regulated environment.
- Ability to collaborate effectively with Quality, IT, Packaging, Manufacturing, Supply Chain, Engineering, Automation, and external partners.

Skills CSV, SAP ICH, EPCIS, FDA 21 CFR Part 11

📌 Lead I - Software Testing (Hyderabad)
🏢 UST
📍 Hyderabad