Serialization Packaging Engineer
Locations: Raleigh, NC/ Concord, NC/ Indianapolis, IN

Introduction: The Serialization Packaging Support Engineer is responsible for providing technical support and ensuring compliance for serialization systems on packaging lines. This role involves troubleshooting, maintaining, and improving serialization hardware and software to meet global regulatory requirements and company standards.

Responsibilities:

• Provide day-to-day technical support for serialization systems (vision systems, printers, scanners, PLCs) in a 24/7 support environment.
• Troubleshoot and resolve serialization-related issues on packaging lines.
• Execute equipment qualification (IQ/OQ/PQ) for serialization components.
• Collaborate with automation and IT teams for integration of MES, SCADA, and serialization systems.
• Collaborate with IT teams for system integration, database management, and network connectivity.
• Ensure compliance with GMP, DSCSA, EU FMD, and other regulatory requirements.
• Participate in audits and provide necessary documentation for serialization systems.
• Manage incidents and changes through established governance processes.
• Work with vendors and cross-functional teams to implement upgrades and improvements.
• Analyze performance data and recommend process optimization strategies.
• Maintain accurate documentation for serialization systems and procedures.

Requirements:

Required Skills:

• Technical: Industrial automation, PLC programming, vision inspection systems, SQL databases.
• Domain Knowledge: Pharmaceutical serialization solutions (Systech, Antares, Seavision, Tracelink).
• Compliance: GMP processes, packaging qualification standards.
• Soft Skills: Problem-solving, multitasking, cross-cultural communication, ability to work independently.
• Experience with Systech or similar Pharma serialization and packaging solutions (Systech – Guardian, Advisor, and Centri systems).
• Experience with SQL databases and network troubleshooting.
• Knowledge of SCADA systems and MES/OEM integration.
• Ability to work independently and in a global team environment.
• Strong documentation and reporting skills.

Preferred Skills:

• IQ, OQ, PQ
• Pharmaceutics
• SCADA
• Serialization
• PLC
• Packaging