MBR Developer - Werum PasX & Opstrakker

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 videoand check out our Diversity Equity and Inclusion actions at sanofi.com!