Platform Validation Engineer - Serialization (TraceLink)

Job Title: Platform Validation Engineer - Serialization (TraceLink)

Experience: 5+ yrs
Location: Hyderabad (Hitech City area)
Employment Type: Full-Time
Shift Time: 02:00 pm to 11:00 pm ( 5days WFO)

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.

 

Skills:
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.