Master Batch Record (MBR) Designer

Job description

Position Title: Master Batch Record Designer (electronic records)

Department : B100 IMS (New Vaccine Manufacturing Facility)

Sanofi Pasteur: The world’s leading vaccine company

 

Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines.  Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe.  Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases.

 

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.  With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Mission:

The Master Batch Record (MBR) Designers (electronic records) team is responsible for modeling the manufacturing processes in a Manufacturing Execution System (MES) PAS|X.. The MBR Designer will work closely with key stakeholders is a variety of departments (change to closely with key stakeholders cross-functionally) to ensure that all operational requirements are met and the execution processes are fully integrated with ERP, PCS and data historian. The MBR Designer will also participate the testing and validation of the MBR .

Building 100, a new Vaccine manufacturing facility being constructed at our Toronto site, is an extremely exciting and complex project that will position Sanofi Pasteur on the cutting edge of the digital evolution of biopharmaceutical manufacturing. The Integrated Manufacturing Solutions (IMS) team is at the forefront of the transformation and this position will challenge individuals to work as part of dynamic, cross functional and multi-disciplinary team both locally and globally.

Key Accountabilities:

Support the different stages of the B100 project:

·  Lead workshops to gather user requirements.
·  Design manufacturing processes in MES system PAS|X.
·  Translate business needs and processes into manufacturing systems functionality and configuration.
·  Find and implement solutions to identified gaps between operational processes and systems functionality.
·  Responsible for System Configuration and Master Data Management activities.
·  Author test cases against system functional specification.
·  Train end users.

Education and Experience:

·  Minimum University degree
·  Minimum 1 year experience in the documents/E-Systems and quality/compliance
·  Minimum 3 (three) years in pharmaceutical or related industry demonstrated understanding of Good Manufacturing Practices (GMP), Health and Safety, and Quality standards
·  Demonstrated success in project (role is currently working in project mode: planning, designing, execution)
·  Demonstrated Execution Systems knowledge (MES, PCS, Data Historian, PAS|X) is preferred
·  Ability to train users on system functionality
·  Technical knowledge: GAMP, ISA 95, ISA 88, CFR part 11 is preferred
·  Ability to communicate technical solutions to business language
·  Demonstrated ability to work independently within project matrix structure

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to a ttract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants.  Accommodations for persons with disabilities required during the recruitment process are available upon request.

 

Thank you in advance for your interest.

Only those candidates selected for interviews will be contacted.

 

Sanofi, Empowering Life

#GD-SP   

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.