Technologist, Pharmaceutical Manufacturing, Quality Engineering

Reference no
:

R2872730

Position title:Technologist (Night Shift)

Duration:Fixed Term Contract
-3 years

Location:Toronto, ON

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and  Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

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,fueledby data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.

We’rean 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.

• 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…