Technologist
PharmaBiotechQuality Assurancegmpemacroinform
Job description
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. 5. Participate in continuous process and equipment improvement, Health, Safety & Environment, Quality, and Inspection readiness initiatives Perform and participate in continuous improvement and development projects. Initiate Deviations, CCR, CAPA in Quality system as needed and assist until completion as per committed due dates Participate in deviation investigations and root cause analysis. Follow HSE SOPs, identify and minimize risks, promote safety culture. Comply with HSE guidelines on the disposal of waste. No employee has a proprietary right to an activity or group of activities. Activities may be changed or reassigned to meet the needs of the operations. About You Education : Minimum (3) three years College's diploma degree (Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences), plus a minimum of (1) one year of previous relevant work experience. Skills and Knowledge: 1. Functional, Technical or Scientific Purification Process for viral proteins Production Equipment Aseptic Technique Current Good Manufacturing Practices (cGMPs) Chemistry, Microbiology, Biochemistry, Mathematics, Computer Mechanical Aptitude Hours Of Work: Inclusive from Sunday to Thursday/ Tuesday to Saturday/ Friday to Tuesday 10:00 PM - 6:00 AM. This is subject to change at any time and it should not be construed as limiting the right of the company to make such a change to meet the requirements of the operation. Pay rate - $49.34 per hour Mandatory Application Requirement: Your Workday application form must be complete, and a copy of your resume MUST be attached in the Workday application form, at the time you submit your Workday application, otherwise your application will not be considered for this position Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness program This position is for a new vacant role that is now open for applications. AI Usage "Artificial Intelligence” refers to any systems that use automated processes, including algorithms and machine learning, to analyze data and make predictions, inferences, decisions, or recommendations without direct human involvement. These systems may process personal information to identify patterns, improve services, or support decision-making. The Company may use Artificial Intelligence for purposes including, but not limited to, resume screening and hiring, scheduling interviews or meetings, conducting surveys, matching skills with potential job openings, interview scoring, ensuring compliance with regulations applicable to our industry, and activities related to performance evaluation. Information collected and processed by the Company’s Artificial Intelligence systems may include the personal information detailed above and calendar availability. It exclude
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