Technologist - Flu Downstream

Reference No. R2705658
Position Title: Technologist
Duration: Fixed-Term Contract (September 18, 2023 - August 16, 2024) Potential for extension
Department: Downstream Flu Operations
Location: Toronto, Ontario
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.
Major Activities of the Job:
Execute downstream processing, sterile filtration of Influenza drug substance:

• Execute and verify IQ/OQ/PQ validation and cleaning verification protocols.
• Provide training to personnel.
• Clean-in-place (CIP), cleaning-out-of-place (COP) of downstream equipment and vessels.
• Perform troubleshooting and assessment of processes and technical problems.
• Set up, maintain a variety of automated and manually operated equipment and perform production activities in downstream processes: centrifugation, TFF, inactivation, and sterile filtration of drug substance.

Perform sampling and analytical tests- utility sampling, environmental monitoring and area-specific testing:

• Perform area-specific testing, utility sampling and environmental monitoring for production.
• Deliver samples to other departments on site as required.
• Sample processed materials and perform in-process testing according to procedures.

Maintenance of clean rooms, equipment, inspection readiness:

• Maintain and organize cleanroom in good cGMP state and ensure area is always inspection ready.
• Perform routine cleaning and disinfection activities in classified environments.
• 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.

Administration of data for Influenza. drug substance operations:

• Follow all SWI/SOPs and comply to site policies and procedures.
• 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.
• Document, review and maintain production and monitoring activities for Influenza drug substance manufacturing.

Participate in continuous process and equipment improvement, Health, Safety & Environment, Quality, and Inspection readiness initiatives:

• Comply with HSE guidelines on the disposal of waste.
• Initiate Deviations, CCR, CAPA in Quality system as needed and assist until completion as per committed due dates.
• Perform and participate in continuous improvement and development projects.
• Participate in deviation investigations and root cause analysis.
• Follow HSE SOPs, identify and minimize risks, promote safety culture.

Minimum Qualifications:

• Stress/Time Management and Conflict Resolution.
• Current Good Manufacturing Practices (cGMPs).
• Purification Process for viral proteins.
• Production Equipment.
• Interpersonal / Teamwork.
• Chemistry, Microbiology, Biochemistry, Mathematics.
• Aseptic Technique.
• Communication I Networking.
• Computer.
• Mechanical Aptitude and Technical Writing.
• Minimum three (3) years College Diploma ( Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences ) plus a minimum of one (1) year of previous relevant work experience.
• Preferred four (4) years Bachelor’s Degree ( Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences ) plus a minimum of one (1) year of previous relevant work experience.

Hours Of Work:

• Inclusive from Monday - Friday: 8:00 a.m.- 4:00 p.m (Subject to Change)

Pursue Progress.
Discover Extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com!
Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.
Thank you in advance for your interest.
Only those candidates selected for interviews will be contacted.
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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.