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IMS Technical Writer (Building 100)

Toronto, Canada

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Job ID R2522764 Date posted 10/21/2019

Position: IMS Technical Writer
Reference: R2522764
Location:  Sanofi Pasteur Limited / North York, Ontario
Department:  Toronto / Bulk Manufacturing

Mission:


The Technical Writer will ensure that quality documentation for B100 processes and systems are developed to ensure alignment to quality requirements while taking full advantage of computerized system capabilities. This position requires a great deal of creativity while balancing interaction with multiple departments include ITS, Operations, MTech, Quality and Automation.

Key Responsibilities:

  • Responsible for creation/maintenance of SOPs and Work Instructions related to computerized systems within the scope of IMS, ensuring alignment with site quality and regulatory requirements.
  • Liaise with multiple stakeholders (both project and site) to understand how system best practices can be met while respecting quality/compliance standards.
  • Manage and maintain all quality documentation specific to IMS.
  • Ensure documents are delivered to support B100 project timelines.
  • Support development and delivery of End User training.

Education & Experience:

  • Minimum University/College degree or must have relevant work experience in the documents/E-Systems and quality/compliance
  • Experience with Integrated Manufacturing Systems and Industry 4.0 including: ERP, MES (Emerson/Siemen), SCADA, OSISoft Pi Historian, DeltaV record, Werum PAS|X would be an asset
  • Experience in pharmaceutical manufacturing, 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 (For the represented area) such as (but not limited to) Equipment Prep, Media dispensing Media Formulation, Fermentation, Purification and Adsorptions
  • Demonstrated understanding of current Good Manufacturing Practices, Health and Safety, high quality standards, industry standards and their application to the manufacturing process
  • Ability to effectively communicate with internal and external team members.
  • Strong analytical skills and hands‐on troubleshooting skills.

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.

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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