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Sanofi Group Manufacturing Execution System (MES) Specialist in Toronto, Ontario

Manufacturing Execution System (MES) Specialist

Department : IMS B100 (New Vaccine Manufacturing Facility)

Sanofi Pasteur: The world’s leading vaccine company .

Building 100, a new Vaccine manufacturing facility being constructed at Sanofi’s 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.

Mission:

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

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:

  • Demonstrated MES system knowledge in PAS|X/Pas-X is highly preferred

  • 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)

  • 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 attract, 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 #LI-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.

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