MES Engineer - Pharmaceutical Manufacturing
The International Society for Pharmaceutical Engineering, Inc., Holly Springs, NC, United States
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 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 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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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 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 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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