MBR Developer - Werum PasX & Opstrakker

Role Overview

• The MBR Developer is responsible for building, testing, and implementing Master Batch Records (MBRs) and related components within the Manufacturing Execution System (MES). You will ensure that MBR configurations align with the Core model and operational excellence standards while adhering to Sanofi Digital and Industrial standards for Processes, Applications, and Infrastructure environments.
• Working in close collaboration with MES Digital Product Configuration Manager, MES Digital Product Configuration Experts, MES Product Owner, MES installers/developers, Product lines, local digital teams, Business Process Owners, and Site modelers, you will contribute to the successful implementation of MES solutions across Sanofi manufacturing sites.

Systems & Processes in Scope

• Main MES Systems:
• Werum PasX MES Product (Korber)
• Opstrakker (elogbook/ eforms)

• Business Processes Covered:
• Master data management (items, user rights, equipment, locations, work orders)
• Master batch record design & approval (including workflows)
• Master batch record review & approval (by Exception)
• Production execution
• Weighing & Dispensing
• Communication to equipment or SCADA systems
• Equipment management
• Material flow management
• Traceability / Genealogy
• Labelling
• Reporting
• Interface with ERP, quality, logistics & shopfloor systems (LIMS, Documentation, Deviation management, Serialization, eOEE)

Main Responsibilities

• Business Alignment
• Understand business requirements and contribute to building & testing solutions
• Support the implementation of appropriate services to ensure optimal allocation of available capabilities
• Contribute to end-to-end business process analysis including integration with partner systems
• Collaboration & Skills Development
• Contribute to Digital skills development within your domain
• Collaborate effectively in a matrix environment

Delivery & Quality of Services

• Build and test MBRs, Process Instructions, blocks, and templates according to specifications provided by DevOps Engineers / following established guidelines
• Develop and maintain test scripts for MBR validation
• Follow established build and test methodologies by adopting GxP validations
• Perform or participate in regular MBR reviews for sites
• Configure & implement core solutions as close to standard market solutions as possible
• Ensure solution builds are aligned with user requirements & core model
• Ensure technical solutions comply with recommendations for Quality, Security, and Accessibility
• Support the proper deployment of core solutions
• Ensure standards of Platform Management (Release, solution documentation, testing) are followed
• Contribute to the on-time delivery of projects
• Support impact analysis of configuration changes
• Troubleshoot and resolve technical issues during MBR implementation
• Document technical aspects of MBR configurations
• Support system testing and validation activities
• Support the implementation of configuration changes following change control procedures
• Manage incidents & corrective/preventive actions

Quality and Compliance

• Track and report on established KPIs for quality of service
• Ensure all configurations meet GMP requirements and data integrity standards
• Maintain configuration documentation in alignment with validation requirements

About You

Experience & Knowledge

• 3-5 years work experience in Digital Manufacturing/MES specifically on Werum PasX (Korber) and Opstrakker (elogbook/ eforms)
• MES experience with relevant solutions/modules/functionalities
• Experience working in multicultural/matrixed environments
• Experience & understanding of core product/model concept
• Experience working in industrial plants is preferred but not mandatory

Technical Skills

• Knowledge of MES solutions: Werum PasX MES Product (Korber) & Opstrakker (elogbook/ eforms)
• Knowledge of pharma industry regulatory context (GxP)
• Knowledge of Digital technologies & concepts
• Knowledge of Automation layer (SCADA, DCS, PLCs) is a plus
• Knowledge of scripting (VB/.Net) and JSON is a plus

Soft Skills

• Accountability and reliability
• Good mindset - quick learner, proactive, willing to apply change management
• Collaboration and good team player
• Ability to deal with ambiguous situations
• Focus on value delivery, with the ability to work on solution build and testing and proactiveness within the assigned scope
• Knowledge of Agile methodologies

Education

• Engineering degree in Computer Science or related field

Language

• Fluent in English, other languages are a plus

Working Environment

• Travel requirement: Occasional travel to manufacturing sites
• Global, matrix organization environment
• Must be able to work effectively across different time zones and cultures