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. • Strong 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 setting. • 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

About UST
UST is a global digital transformation solutions provider. For more than 20 years, UST has worked side by side with the world’s best companies to make a real impact through transformation. Powered by technology, inspired by people and led by purpose, UST partners with their clients from design to operation. With deep domain expertise and a future-proof philosophy, UST embeds innovation and agility into their clients’ organizations. With over 30,000 employees in 30 countries, UST builds for boundless impact—touching billions of lives in the process.

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