Serialization Engineer

Stanley David and Associates; Indianapolis (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

A pharmaceutical consulting firm in Indianapolis is seeking a Serialization Packaging Support Engineer. In this role, you will provide technical support for serialization systems used in packaging, ensure compliance with global regulatory standards, and troubleshoot various issues on packaging lines. Strong experience with pharmaceutical serialization solutions and effective communication skills are essential. You will also collaborate with IT and automation teams, manage incidents, and maintain documentation. This position requires an ability to work both independently and as part of a global team.

Qualifications

• Experience with pharmaceutical serialization solutions like Systech, Antares, Seavision, Tracelink.
• Knowledge of SQL databases and network troubleshooting.
• Ability to work independently and collaboratively in a global team.

Responsibilities

• Provide technical support for serialization systems in a 24/7 environment.
• Troubleshoot serialization issues on packaging lines.
• Ensure compliance with GMP, DSCSA, EU FMD regulations.
• Maintain documentation for serialization systems.

Skills

Pharmaceutical serialization solutions

Problem-solving

Multitasking

Cross-cultural communication

Systech/Guardian/Advisor/Centri

SQL databases

SCADA systems

Documentation and reporting skills

Job description

Serialization Packaging Support Engineer

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.

Required Skills

• Domain Knowledge: Pharmaceutical serialization solutions (Systech, Antares, Seavision, Tracelink).
• 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.

Key Responsibilities

• Provide day-to-day technical support for serialization systems (vision systems, printers, scanners, PLCs) in 24/7 support environment.
• Troubleshoot and resolve serialization-related issues on packaging lines.
• 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.