Pharmaceutical Serialization Specialist

Job Summary Seeking an experienced Pharmaceutical Serialization Specialist with strong knowledge of serialization, aggregation, track & trace systems, and global pharmaceutical regulatory compliance. Candidate will support implementation, integration, validation, and maintenance of serialization solutions.

Roles & Responsibilities

• Implement, configure, and support pharmaceutical serialization and aggregation solutions.
• Manage serialization processes across L1–L5 systems.
• Ensure compliance with global regulations, including US DSCSA, EU FMD, and applicable GS1 standards.
• Integrate serialization solutions with ERP, MES, packaging lines, and external systems.
• Handle EPCIS data exchange, serial number management, and product traceability.
• Troubleshoot serialization, aggregation, data exchange, and system integration issues.
• Coordinate with technical teams, vendors, and clients for implementation and support.
• Prepare technical documentation, validation reports, and SOPs.
• Support system testing, UAT, deployment, and production activities.
• Monitor serialization system performance and resolve operational issues.

Required Skills & Qualifications

• Minimum 3 years of experience in pharmaceutical serialization or track & trace.
• Strong understanding of serialization architecture (L1–L5).
• Knowledge of GS1 standards, GTIN, SGTIN, SSCC, and EPCIS.
• Experience with serialization platforms such as TraceLink, SAP ATTP, Systech, Antares Vision, or similar.
• Understanding of aggregation, commissioning, decommissioning, and reconciliation.
• Familiarity with REST APIs, XML, JSON, and system integration.
• Knowledge of pharmaceutical regulatory compliance and validation processes.
• Strong analytical, communication, and problem-solving skills.

Preferred Skills

• Experience with international pharmaceutical serialization projects.
• Knowledge of ERP/MES integrations.
• Understanding of GxP, GAMP 5, and CSV/CSA validation practices.
• Experience with cloud-based track & trace solutions.
• Client-facing implementation and technical support experience.