Hyderabad, India
5 days ago
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 video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Por favor confirme su dirección de correo electrónico: Send Email