Job Description:

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 workplace. · Ability to collaborate effectively with Quality, IT, Packaging, Manufacturing, Supply Chain, Engineering, Automation, and external partners.

Skills:

TraceLink, SAP, EPCIS, ServiceNow

About Company:

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 (Bengaluru)
🏢 UST
📍 Bengaluru