Technologist - Vaccine

R 2865843 Technologist - Vaccine

Duration:
Fixed Term Contract - 9 months

Location:

Toronto, ON

Night Shift multiple openings

Join the team protecting half a billion lives every year with next-gen science, mRNA innovation, and AI-driven breakthroughs. In Vaccines, you'll help advance prevention on a global scale - and shape the future of immunization.

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.

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.

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).

• 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.

• 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.

• 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.

• 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

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…