Lead I - Software Testing

UST; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

UST seeks an experienced Validation Engineer for Serialization and TraceLink focus in Hyderabad. The role requires CSV expertise in pharma with 5+ years of experience, deep knowledge of 21 CFR Part 11, EU Annex 11, and GAMP 5, and hands-on traceability across serialization networks.

You will develop validation docs, execute IQ/OQ/PQ, and ensure audit-ready records. Responsibilities include validating TraceLink applications and integrations, managing EPCIS data exchanges, and supporting changes

Qualifications

• Five years of CSV experience in pharma or life sciences.
• Hands-on serialization/Track Trace with TraceLink exposure.
• Strong knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, 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.

Responsibilities

• Plan, author, review, and execute CSV activities for GxP-regulated serialization and Track Trace systems.
• Validate TraceLink or equivalent serialization applications, interfaces, and integrations.
• Develop and maintain validation documentation including IQ/OQ/PQ protocols and RTMs.
• Execute functional, integration, regression, and end-to-end validation testing.
• Validate serialization processes including serial-number management, EPCIS data exchange, and regulatory reporting.
• Maintain traceability among requirements, risks, test cases, defects, and validation evidence.
• Support changes, upgrades, patches, and integrations through change-control and validation processes.
• Prepare inspection-ready validation documentation for audits and regulatory reviews.

Skills

CSV Validation

TraceLink

GxP Compliance

Documentation

Regulatory Reporting

Tools

ServiceNow

Job description

Job Summary

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