MES - Syncade Engineers
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Job Description
Role: MES Engineer 4 openings
Duration: 1+ years
Location: Remote with initial 2-4 weeks onsite expenses paid for training, then ad hoc travel to the site as needed, likely once per quarter
Must Haves:
- 5+ years of hands-on experience with Syncade MES in a regulated manufacturing environment
- Strong understanding of MES validation (IQ/OQ/PQ) and GxP requirements
- Experience supporting Syncade MES code migration, system upgrades, or major configuration changes
- Familiarity with:
- Electronic Batch Records (EBR)
- Recipe management and execution
- MES testing methodologies
- Experience working in biotech, pharma, or life sciences manufacturing
- Ability to work in a fast paced project environment with evolving priorities
Preferred Experience
- Prior experience supporting greenfield or large program initiatives
- Exposure to deltaV ECS or phased MES system migrations
- Strong documentation skills in regulated environments
Role Overview
Insight Global is seeking multiple MES Syncade Engineers to support its expansion. This is a critical effort focused on qualification, validation, and migration of MES production systems.
This role will play a key part in transitioning MES functionality through IQ/OQ/PQ and into production, followed by Syncade code migration, testing, and stabilization to support future-state manufacturing operations.
The ideal candidate brings hands on experience with Syncade MES, a strong understanding of GxP validation, and has supported code migration and system testing activities in regulated manufacturing environments.
Key Responsibilities
MES Migration & Technical Execution
- Support Syncade MES code migration activities, including analysis of existing logic, modules, recipes, and workflows.
- Execute and support MES build updates, configuration changes, and refactoring as part of migration efforts.
- Collaborate with automation, IT, and manufacturing teams to ensure alignment between control systems and MES layers.
- Troubleshoot MES issues during migration, testing, and early production support
Qualification & Validation Support
- Participate in IQ/OQ/PQ activities for MES production systems
- Support development and execution of validation documentation (URS, FRS, Traceability Matrices, Test Scripts, Protocols, Deviations)
- Execute and document functional testing, regression testing, and user acceptance testing (UAT)
- Ensure MES solutions meet GxP, data integrity, and Fujifilm quality requirements
Production & Manufacturing Support
- Provide MES support during commissioning, qualification runs, and initial production
- Partner with Manufacturing, Quality, and Operations to resolve MES related issues impacting batch execution
- Support recipe execution, EBR workflows, exception handling, and system enhancements
Collaboration & Project Support
- Work cross functionally with:
- Automation & Controls
- CSV / Validation
- Quality Assurance
- Manufacturing & MSAT
- IT / Digital Systems
- Contribute to project documentation, change control, and technical decision making.
- Support knowledge transfer and handoff activities as systems transition to steady state operations.
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