Configuration Lead MES
On-siteToronto, Ontario, Canada
Job Summary
Design and build core MES solutions for Sanofi's global manufacturing network, driving architecture, configuration, and lifecycle management of Siemens Opcenter Execution Pharma and Körber PAS-X platforms. Translate business needs into standardized, compliant designs ensuring core model consistency across multi-site deployments while diagnosing complex technical issues and applying scripting for automation. Conduct end-to-end process analysis for integrations with ERP, LIMS, SCADA, and labeling systems, managing risks to ensure on-time, cost-effective delivery aligned with GxP, Data Integrity, and 21 CFR Part 11 standards. Provide expert functional leadership to configuration teams, facilitate knowledge transfer, and benchmark technology trends to adapt operating models for next-generation technologies including Cloud and Agile methodologies.
Required Qualifications
- 5+ years of experience in MES / Industrial IT
- Experience in a regulated Pharmaceutical / Life Sciences environment (GxP)
- Multi-site, international, and/or matrix organization experience
- Experience gained in pharma, biotech, consulting, or as a vendor/system integrator
- Strong expertise in pharmaceutical MES solutions
- Siemens Opcenter Execution Pharma experience
- Master Batch Record (MBR), Review by Exception, MES modules, and system integrations
- Scripting skills: SQL, VB.NET/C#, Python, or MES platform-specific languages
- GxP, Data Integrity, CSV/CSA, and GAMP5
- Solution architecture and ERP/LIMS/shopfloor integrations
- Understanding of automation environments including SCADA, DCS, PLCs, and industrial protocols
- Engineering degree or Master's degree in Computer Science, Industrial IT, Automation, or equivalent professional experience
- English mandatory
- French appreciated
Desired Qualifications
- Knowledge of Körber PAS-X
- Low-code application development using Mendix
- AI-assisted development tools (GitHub Copilot, Claude, Microsoft Copilot, etc.)
- Cloud architecture and services (Azure preferred)
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