Technologist

Reference no : R2872730 Position title: Technologist (Night Shift) Duration: Fixed Term Contract - 3 years 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. Execution of Media, Buffer, Washing, and Sterilization & Inoculation preparation activities Assist in review of Records, SOP, logbooks, and monitoring charts for completion and ensure accuracy of all documents as per GMP guidelines. Train and ensure technical staff comply to GMP, HSE, and SOP requirements. Participate in daily meetings and report findings to management. Participate in deviation investigations and root cause analysis. Coordinate with units within department (MWS, Upstream and Downstream) 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 (MWS, Upstream and Downstream processes). 2. Preparation of media, buffer, washing and sterilization, inoculum, analytical testing, area monitoring, maintenance, material handling, warehouse Perform activities and documentation involved in MBWS and Upstream including, in buffer preparation, washing and sterilizing, inoculation preparation, infectivity testing, and material handling. Perform production calculations, measurements, and release checks. Ensure each cleaning meets standards set in SOP, records, and in accordance with GMP. Observe in detail and report any process deficiencies, perform visual inspection of equipment for impurity and damage before and after cleaning. Perform utility sampling and environmental monitoring as required and ensure the completion as adhered to schedule. Provide guidance to technical staff on problem solving and trouble shooting. Ensure area is inspection ready. Knowledgeable to guide inspectors. Material handling, movement an organization and storage. Reorder parts as per guidance from TGL's. 3. Administration of data for drug substance operations and preparation of trending reports for analysis Document and review production and monitoring activities for drug substance manufacturing Complete SAP transactions in a timely, accurate manner. Draft, review and revise cGMP documents (SOPs/SWis, batch records, protocols, change controls, reports and other manufacturing supporting documents). Ensure all data is completed timely and accurately in LIMS, Master, Change Request Forms, PCS and EM svstem. 4. Health, Safety and Environment and maintenance of GMP environment Participate in keeping the production area and office areas in a tidy, GMP manner, following 5S guideline or equivalent and supply materials as required Disinfect area as required in SOP. Assist to ensure loading dock and hallways are clean and unobstructed by materials or equipment, garbage is discarded daily to designated area outside production. Use proper PPE when performing tasks. Follow HSE SOP's, identify and minimize risks, promote safety culture. Ensure chemicals are stored as per HSE requirement and has MSDS available. 5. Process improvement and development Assist implementation of facility, equipment, and process improvement projects. Assist in writing specifications, protocols and reports related to facility, equipment, and process improvement of production process. Modification of SOPs and BPR's for new processes in accordance with change control policies. Perform activities involved in IQ, OQ, and PQ for new equipment. Initiate Deviations, CCR, CAPA in Quality system as needed and assist until completion as per committed due dates. Collaborate with other departments for root cause analysis and assist with implementation of corrective actions. About You ​ Education: Minimum (3) three years College Diploma or equivalent (Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences, other Life Science, (or equivalent education) plus a minimum of one (1) year and six (6) months of previous relevant work experience. OR (4) four years Bachelor's degree (Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences, other Life Science, or equivalent) plus a minimum of (1) one year of previous relevant work experience. Skills and Knowledge: Functional, Technical or scientific Purification Process for viral proteins Production Equipment. Aseptic Technique. Current Good Manufacturing Practices (cGMPs). Knowledge and experience in Chemistry, Microbiology, Biochemistry. Mathematics, Computer, Mechanical Aptitude, Technical Writing, Quality and Improvement, Safety. Supervisory, Managerial and Personal Communication I Networking Interpersonal / Teamwork Stress/Time Management Conflict Resolution Hours Of Work: Inclusive from Sunday to Friday, 10 pm to 6 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. 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 he