Integrated Manufacturing Solution (IMS) Technical Writer (Vaccines)
Location: Sanofi Pasteur Limited (Toronto)
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.
Integrated Manufacturing Solution (IMS) Technical Writer (Vaccines) Mission:
In the scope of the new building, B100, the Toronto Sanofi Pasteur site will be an integration of different electronic solutions aimed at delivering vaccine product within a controlled environment. The IMS Technical Writer supports this implementation for the business and focus’ on electronic solutions for manufacturing including electronic batch record creation. This position requires interaction with the IS, Operations, Manufacturing Tech, Quality and Automation teams.
Integrated Manufacturing Solution (IMS) Technical Writer (Vaccines) Responsibilities:
- Understanding and collecting user requirements for equipment and technology and translating into core system functionality (EDK library creation, SOP, training and best practices documentation)
- Become a subject matter expert to help build the Manufacturing Execution System (MES) from concept to adaptation/production of the B100 manufacturing processes
- Coordinate the design phase ensuring alignment of the different stakeholders (Manufacturing, Quality) 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 taking into consideration the specifications of each software package.
- Support Operation Users in their training and usage of the integrated manufacturing systems including but not limited to: ERP, MES, SCADA, Historian, and Data mining awareness
- Data trending, EM trending, and data for MES / Pi / DeltaV record creation (equipment, holding time associated, critical parameters)
- Creating and building the required electronic batch records
- Support validation of the systems and writing of the users acceptance test cases, and execution of the UAT
Education & Experience:
- Minimum University degree
- 2 years’ experience in GMP with knowledge of technical documentation for quality/compliance/production
- Technical writing ability to document process/procedure, and suggest improvements within new technology/instrumentation capabilities
- Ability to contribute as a subject matter expert (SME) within a matrix team and within IMS/MES group
- Confidently contribute as a SME with ability to suggest changes to current process/practice using strong analytical skills
- Ability to develop training and provide guidance for new systems for qualifying personal/operators to enter GMP environments/facility
- OSISoft PI historian, Werum PAS|X, Emerson/Siemen MES system experience is a nice to have
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
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.