Job Description
Role Overview
Insight Global is seeking multiple MES Syncade Engineer’s to support their 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, 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:
o Automation & Controls
o CSV / Validation
o Quality Assurance
o Manufacturing & MSAT
o 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
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Required Skills & Experience
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:
o Electronic Batch Records (EBR)
o Recipe management and execution
o MES testing methodologies
• Experience working in biotech, pharma, or life sciences manufacturing
• Ability to work in a fast paced project environment with evolving priorities
Nice to Have Skills & Experience
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
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.