Release Train Engineer managing end - to - end execution and governance in agile product transformation. Leading a cross - functional team and promoting an engineering - centric culture in a hybrid work model.
TT
Hybrid Manufacturing Execution System Engineer – Level 3
Posted last week
About the role
- MES Engineer driving Product Lifecycle Excellence at Terumo, handling MES deployment and data analytics in a GMP-regulated setting.
Responsibilities
- Support deployment, integration, configuration, and roadmap of MES platform(s)
- Act as the primary site owner/SME for MES usage, training, documentation, and troubleshooting
- Design and optimize process flows, electronic work instructions, and conditional routing to streamline manufacturing operations
- Develop and maintain core dashboards, KPIs, and reports
- Enable teams to self-serve analytics and data visualization for day-to-day execution
- Evaluate current-state processes and product lifecycle workflows
- Lead Digital Ops Excellence (DOX) projects using Lean or Six Sigma
- Define data architecture and standardized methods for collection, processing, and storage of manufacturing data
- Champion data quality, governance, and traceability across MES, ERP, PLM, and IIoT sources
- Implement and adhere to GMP practices, ISO 13485, and FDA regulations
Requirements
- Bachelor of Science in Engineering (Industrial, Mechanical, Electrical, Chemical, Systems or related)
- 5 years of experience in a manufacturing environment; medical device or life sciences preferred
- Experience with MES validation (IQ/OQ/PQ)
- Minimum 2 years under GMP in a regulated environment
- Hands-on experience implementing and/or owning MES (e.g., Siemens Opcenter, Critical Manufacturing, SAP, Tulip, Rockwell Automation Plex)
- Basic scripting or low-code development (e.g., Mendix, Tulip connectors)
- Knowledge of FDA regulations, ISO 13485, and validation practices
Benefits
- Multiple group medical, dental and vision plans
- Robust wellness program
- Life insurance and disability coverages
- 401(k) plan with a matching contribution
- Vacation and sick time programs
- Variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance
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