What are the responsibilities and job description for the Serialization Packaging Engineer position at Fusion Plus Solutions, Inc.?
Role: Sterialization Packaging Engineer
Location: WALTHAM, MA
Duration: Long term Contract to Hire
Role Descriptions: 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 ensure compliance with global regulatory requirements and company standards.
This role requires working in 24/7 in-person shift environments and no possibility of remote work
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, and the ability to work independently
- Experience with Systech or similar Pharma serialization and packaging solutions (Systech β Guardian, Advisor, and Centri systems)
- Experience with SQL databases and network troubleshooting.
- Knowledge of SCADA systems and MES/OEM integration.
- Good communication skills, both in English and German
Key Responsibilities:
- 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, and other regulatory requirements.
- Participate in audits and provide necessary documentation for serialization systems.
- Maintain accurate documentation for serialization systems and procedures