Technologist

Reference no :  R2876189 Position title:   Technologist Duration:  Fixed Term Contract  - 8 months. Location:   Toronto, ON   About the Job   Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.​    Sanofi Vaccines   Sanofi's global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being.    At Sanofi, we chase the miracles of science to improve people’s lives.  We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.     About Sanofi    We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.     Main Responsibilities:   1. Execute downstream processing, sterile filtration of lnfluenza drug substance • Set up, maintain a variety of automated and manually operated equipment and perform production activities in downstream processes: clarification by centrifugation and TFF, purification by zonal centrifugation, splitting by continuous flow centrifugation, inactivation, diafiltration and sterile filtration of drug substance. • Perform troubleshooting and assessment of processes and technical problems. • Clean-in-place (CIP), cleaning-out-of-place (COP) of downstream equipment and vessels. • Provide training to personnel. • Execute and verify IQ/OQ/PQ validation and cleaning verification protocols. • Perform other duties as assigned by department management throughout all stages of drug substance manufacturing related to B200 operations (MWS, Upstream and Downstream processes). • Ensure all equipment, instruments and systems are properly assembled, installed, tested and maintained. • Participate in preventive maintenance of production equipment and instruments. 2. Perform sampling and analytical tests- utility sampling, environmental monitoring and area-specific testing • Sample processed materials and perform in-process testing according to procedures. • Deliver samples to other departments on site as required. • Perform area-specific testing, utility sampling and environmental monitoring for production. 3. Maintenance of clean rooms, equipment, inspection readiness • Perform routine cleaning and disinfection activities in classified environments. • Maintain and organize cleanroom in good cGMP state and ensure area is always inspection ready. • Submit equipment/material orders and maintain inventory of spare parts, purchased materials for downstream processing. • Maintain safe and clean work environment by following site procedures and cGMP regulations. • Participate in facility preparation and inspection readiness, safety and process audits. 4. Administration of data for Influenza drug substance operations • Document, review and maintain production and monitoring activities for Influenza drug substance manufacturing • Draft, review and revise cGMP documents (SOPs/SWis, batch records, protocols, change controls, reports and other manufacturing supporting documents). • Analyze, enter & verify data on paper based or electronic documents. • Follow all SWI/SOPs and comply to site policies and procedures.