About the Job
Company Context
Sanofi's strategic direction is to standardize processes across sites, embrace digital transformation of its Manufacturing & Supply perimeter, simplify its current solution landscape, and leverage advanced technologies to bring business value.
The MARS (MES Accelerated Roadmap @ Sanofi) program aims to implement Computer-assisted batch review, enabled by the definition and roll-out of a core Manufacturing Execution System (MES). This program will transform Sanofi plants, improving compliance, cost, and cycle time performance.
Over recent years, Sanofi has deployed various Production sites across GBUs (multiple pharmaceutical processes, Weighing & Dispensing & full MES), with a second wave currently in motion. This represents a strategic opportunity for Manufacturing & Supply Transformation to:
Design standardized end-to-end processes to generate business value and deliver best-in-class solutions to industrial sites, with high focus on electronic batch record management & review by exception process
Deliver innovative "state of the art" tools enabling performance for manufacturing processes
Allow new generation of deployment – more Agile & business centric
Maintain robust and highly available solutions to operate industrial processes efficiently
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
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
Pursue progress, discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!