MES Engineer - Pharmaceutical Manufacturing

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