IMS Technical Writer
Genzyme
Toronto, ON
13d ago

Reference R2481313

Location : Sanofi Pasteur Limited

Department : Bulk Manufacturing

About Sanofi Pasteur

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 :

In the scope of the new building, B100, the Toronto Sanofi Pasteur site will be an integration of different solutions (ERP, MES, SCADA, Historian, Data mining) aimed at delivering product within a controlled environment.

The Technical writer support this implementation for the business and focus on Electronic solutions for manufacturing. This position requires interaction with the IS, Operations, M-

tech, Quality and Automation teams.

Responsibilities :

Support the different stages of the B100 project :

  • Scoping, collecting user requirements and translating them into core system functionality (EDK library creation).
  • Participate in workshops in order to build the MES detailed concept adapted to the B100 manufacturing processes.
  • Coordinate the design phase in conjunction with ITS : ensure alignment of the different stake holders (Business, Mtech, Quality ) needs, detailed design workshops, review and approval of detailed specifications.
  • Manufacturing process mapping, process analysis, Quality system mapping.
  • Participate in the definition of the functional perimeters of each system (ERP + MES, SCADA + MES) and the exchange rules between the systems while ensuring that they remain as close as possible to the standards of each software package.
  • Support Operations users in the daily usage of the integrated manufacturing systems :

  • ERP, MES, SCADA, Historian, and Data mining awareness.
  • Supporting End User training.
  • Writing of the best practices for systems configuration.
  • Maintain data trending, EM trending, and data analytic for annual product review.
  • Maintain budget to enhance software intelligence to develop Digital 4.0.
  • Support the "Build" phase :

  • Collect the required data for MES / Pi / Delta V record creation (equipment, holding time associated, critical parameters .).
  • Creating and building the required electronic batch records in MES.
  • Support the "UAT" phase : principle of validation of the systems in coordination with Quality, writing of the users acceptance test cases, execution of the UAT.

    Education & Experience :

  • Minimum University / College degree
  • Work experience in the GMP / CSV documents / E-Systems for quality / compliance
  • Experience in electronic processes, document design, operations, quality and compliance
  • Demonstrated ability to work independently within a matrix project team
  • Sound knowledge of unit operations typically used in vaccine manufacturing such as (but not limited to) Equipment Prep, Media Dispensing Media Formulation, Fermentation, Purification and Adsorptions
  • Strong analytical skills and hands on troubleshooting skills.
  • 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.

    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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