IMS Automation SME

Reference No.R2629799

Position Title:IMS Automation SME

Department:B100 MES

Location: Sanofi Pasteur Limited, Toronto

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.

Position Summary:

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 IMS team is at the forefront of this transformation and this position will challenge individuals to work as part of dynamic, cross functional and multi-disciplinary team both locally and globally.

The Building 100 Project involves the implementation of multiple computerized systems to support shop floor operations. Blending a unique combination of project management, IT systems knowledge and pharmaceutical manufacturing skills, the IMS Automation SME will assist with the integration of all electronic systems in B100 by providing the necessary input for proper interaction between electronic batch records, automation, and the data historian. This may include creation of MES master data for system-system communication, modification/improvement to batch recipes in DeltaV, creation of PI Batch Data Tags, and training of B100 Staff in deltaV and other electronic systems At the conclusion of the B100 project, the IMS Automation SME will provide continued support of all electronic systems deployed to secure B100 manufacturing operations.

Key Responsibilities:

• Responsible for troubleshooting of process and equipment automation issues through all stages of the project, including resolution of automation punch list for Production equipment during commissioning: SAT, shakedown, and after project go-live.

• Provide ownership of alarm management: manage alarm notification and response actions/details in a risk-based approach, alarm improvement, etc.

• Provide training on PCS/Delta-V/MES/Pi Systems to operations team and provide ongoing support.

• Draft proposals for automation, recipe, MBR changes (translate user requirements into automation/MES changes), approve changes as the IMS representative and Automation SME.

• Ensure project support and production activities are executed as per defined schedules, monitor & communicate performance using visible metrics.

• Identify and lead initiatives to streamline processes and improve cycle times via procedural and phase changes, increase process efficiency, quality and/or yield; implements solutions or changes via change control; plans and manages facility and organization improvements.

• Where required, liaise with other project stakeholders (Operations, IT, Automation, Quality, Process Development, etc) to ensure the MES/EBRs are built to correctly interface with connected systems (such as ERP, PCS, DHS)

• Provide technical guidance for Operations Teams and MBR design team in order to ensure alignment, design best practices and efficient system function/seamless user experience.

• Support User Acceptance Testing and Go-Live by identifying issues and ensuring required changes are done in MES/EBRs and across all connected systems.

• Following go-live, position will transition to a shop floor support model in order to maintain/continuously improve what was delivered in the course of the project.

Key Requirements:

• Degree in computer science/engineering/Information systems or related discipline or equivalent work experience.

• 5+ years in pharmaceutical or related industry.

• 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 Adsorption.

• Demonstrated Execution Systems knowledge (MES, PCS, Data Historian).

• In particular, strong PCS/Delta V technical skills (Process Automation, system interfacing, etc).

• Demonstrated success in all phases of the project lifecycle including design, development, go-live and Support.

• In-depth knowledge of industry standards (such as Good Manufacturing Practices, GAMP, ISA 95, ISA 88, ISA 18.2, 21CFR part 11 is preferred).

• Excellent written/oral communication 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.

Sanofi, Empowering Life

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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.