Validation Engineer

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 integrations.
• Prepare, review, and maintain validation lifecycle documentation, including:
  • Validation Plans
  • User Requirements Specifications (URS)
  • Functional and Design Specifications
  • GxP and system risk assessments
  • 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.
• Validate serialization processes including serial number management, commissioning, aggregation, partner onboarding, EPCIS data exchange, regulatory reporting, and exception handling.
• Apply risk-based validation methodologies and maintain traceability between requirements, risks, test cases, defects, and validation evidence.
• Document and investigate validation deviations, test failures, defects, and discrepancies, and support timely resolution.
• Support system upgrades, patches, enhancements, integrations, and other changes through established change-control and validation processes.
• Maintain validation documentation in an inspection-ready state.
• Support internal audits, external audits, and regulatory inspections.

Serialization & Track & Trace Responsibilities

• Work with pharmaceutical serialization and Track & Trace platforms, preferably TraceLink.
• Support partner onboarding and end-to-end testing across serialization networks and external partners.
• Validate integrations between serialization platforms, packaging sites, 3PLs, CMOs, MAHs, and supply-chain partners.
• Validate serial number provisioning, pools, ranges, and related CMO/MAH processes.
• Validate serialization events including commissioning, decommissioning, aggregation, disaggregation, packing, unpacking, shipping, and receiving.
• Investigate interface failures, transaction errors, EPCIS issues, and data discrepancies.
• Support serialization requirements across global markets, including the United States, European Union, China, and Canada.

Required Skills & Experience

• 5+ years of hands-on Computer System Validation (CSV) experience in the pharmaceutical, biotechnology, or regulated life-sciences industry.
• Hands-on experience with Serialization or Track & Trace systems.
• Experience with TraceLink is strongly preferred.
• Strong practical knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, GxP, and data integrity principles.
• Experience creating, reviewing, and executing validation documentation and risk-based test protocols.
• Strong experience with requirements traceability, test evidence, validation deviations, defects, and change controls.
• Strong documentation, analytical, troubleshooting, and stakeholder-management skills.

Preferred Skills

• 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, and enhancements.
• Experience with serialization integrations across manufacturing, packaging, supply-chain, and external partner environments.

Tools & Collaboration

• Experience using ServiceNow for RITMs, service requests, incident management, change requests, or change control.
• Experience supporting deviations, CAPAs, change controls, and production issues in regulated environments.
• Ability to collaborate effectively with Quality, IT, Packaging, Manufacturing, Supply Chain, Engineering, Automation, and external partners.