Principal Serialization Engineer

Job Summary

The Senior Serialization Engineer is responsible for the conceptual design, implementation, and validation of serialization and packaging systems across multiple capital and compliance projects—including RFID solutions, cartoners, labelers, case packers, and palletizers. This role leads full project lifecycle execution, encompassing planning, scheduling, resource allocation, technical delivery, and project closure, while ensuring adherence to defined scope, timelines, and budgetary constraints. As the primary subject matter expert for Level 2/3 serialization systems, the Senior Engineer troubleshoots system issues, deploys patches and corrective actions, and ensures ongoing system lifecycle maintenance in alignment with xGMP, Data Integrity, and Computer System Validation (CSV) requirements.

• Lead the conceptual design, implementation, and validation of serialization and packaging systems across capital and compliance projects.
• Manage full project lifecycle activities, including planning, scheduling, resource allocation, execution, and closure while ensuring adherence to scope, timeline, and budget requirements.
• Act as the primary subject matter expert for Level 2/3 serialization systems, performing system troubleshooting, root‑cause analysis, corrective actions, and patch deployments in accordance with xGMP and CSV practices.
• Evaluate, compare, and technically assess proposed serialization and packaging solutions, including benchmarking available market technologies.
• Conduct feasibility studies for new conceptual projects and prepare detailed time, cost, and resource analyses to support go/no‑go decisions.
• Ensure all projects comply with applicable state, federal, and local regulations, including FDA requirements, environmental regulations, OSHA, hazardous materials handling, and company safety standards.
• Coordinate engineering activities among OEM equipment suppliers, system integrators, and validation contractors to eliminate conflicts and ensure safe and compliant execution.
• Author and approve User Requirement Specifications (URS) and participate in design reviews, risk assessments, and engineering change processes.
• Develop and execute FAT, SAT, IOQ/IQ, PQ, change controls, risk assessments, and other CSV/cGMP validation protocols and lifecycle documentation.
• Support the preparation of deviation reports, CAPA actions, non‑conformances, and audit responses related to serialization or packaging equipment and systems.
• Interface cross‑functionally with Packaging Engineering, Operations, IT/OT, Quality Assurance, Validation, Supply Chain, and Regulatory Affairs to ensure system readiness for commercial production.
• Ensure adherence to industry standards such as GS1, EPCIS, DSCSA, EU‑FMD, GAMP5, 21 CFR Part 11, and company internal SOPs.
• Oversee equipment lifecycle activities including installation, commissioning, qualification, maintenance patching, and decommissioning.
• Support personnel training on serialization and packaging systems to ensure correct system usage and compliance.

• Bachelor’s degree in Electrical Engineering, Computer Engineering, or a related technical discipline.
• Minimum of 5 years of relevant industry experience.
• Deep understanding of serialization system architectures (Levels 1–5) and integration between Level 2 equipment and Level 3 enterprise systems.
• Hands‑on experience with serialization platforms such as Systech, PCE, Wipotec, Antares, Optel, or comparable systems.
• Familiarity with packaging line equipment, including cartoners, case packers, palletizers, wrappers, labelers, and vision systems.
• Knowledge of vision system technologies and vendors such as Cognex, Wipotec, Antares, Optel, and PCE.
• Ability to read and interpret mechanical and electrical drawings, P&IDs, and system design documentation.
• Strong understanding of IT/OT interfaces, including OPC UA, MQTT, SQL databases, and XML/EPCIS messaging.
• Working knowledge of DSCSA requirements and EPCIS data exchange standards.
• Understanding of FDA cGMP regulations, 21 CFR Part 11, and GAMP5 system validation frameworks.
• Knowledge of Data Integrity principles (ALCOA+), CSV, and audit expectations.
• Exper…