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About the Role
Join a team protecting lives with next-gen science, mRNA innovation, and AI-driven breakthroughs in Vaccines. Advance prevention on a global scale and shape the future of immunization. Sanofi's global vaccines business unit partners with 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. 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.
Responsibilities
- Execute Media, Buffer, Washing, and Sterilization & Inoculation preparation activities.
- Assist in reviewing Records, SOPs, logbooks, and monitoring charts for completion and accuracy as per GMP guidelines.
- Train and ensure technical staff comply with 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 the 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).
- Prepare media, buffer, washing and sterilization, inoculum, analytical testing, area monitoring, maintenance, material handling, and warehouse operations.
- Perform activities and documentation involved in MBWS and Upstream, including 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 SOPs, 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 completion as adhered to schedule.
- Provide guidance to technical staff on problem-solving and troubleshooting.
- Ensure the area is inspection ready and guide inspectors.
- Manage material handling, movement, organization, and storage.
- Reorder parts as per guidance from TGL's.
- Administer data for drug substance operations and prepare trending reports for analysis.
- Document and review production and monitoring activities for drug substance manufacturing.
- Complete SAP transactions in a timely and 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 systems.
- Participate in keeping production and office areas tidy and GMP compliant, following 5S guidelines or equivalent and supply materials as required.
- Disinfect areas as required by SOP.
- Assist to ensure the loading dock and hallways are clean and unobstructed by materials or equipment, and garbage is discarded daily to designated areas outside production.
- Use proper PPE when performing tasks.
- Follow HSE SOPs, identify and minimize risks, and promote a safety culture.
- Ensure chemicals are stored as per HSE requirements and have MSDS available.
- Assist in the implementation of facility, equipment, and process improvement projects.
- Assist in writing specifications, protocols, and reports related to facility, equipment, and process improvement of the production process.
- Modify SOPs and BPRs for new processes in accordance with change control policies.
- Perform activities involved in IQ, OQ, and PQ for new equipment.
- Initiate Deviations, CCRs, CAPAs in the Quality system as needed and assist until completion as per committed due dates.
- Collaborate with other departments for root cause analysis and assist with the implementation of corrective actions.
Requirements
- Minimum 3 years of College diploma (Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences, other Life Science.) with at least 1.6 years (18 months) of relevant work experience.
- Preferred 4 years of Bachelor’s degree (Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences, other Life Science.) with 1 year of previous relevant work experience.
- 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.
Skills
- mRNA innovation
- AI-driven breakthroughs
- GMP guidelines
- HSE requirements
- SOP requirements
- IQ/OQ/PQ validation
- Cleaning verification
- Production calculations
- Measurements
- Release checks
- Visual inspection
- Utility sampling
- Environmental monitoring
- Problem solving
- Trouble shooting
- Material handling
- Data administration
- Trending reports
- SAP transactions
- cGMP documents
- LIMS
- Master
- Change Request Forms
- PCS
- EM system
- 5S guideline
- Chemical storage
- MSDS
- Process improvement
- SPC analysis
- Change control policies
Location
- Toronto, ON
Work Type
- Fixed Term Contract
- Night Shift
- Onsite
Experience Level
- 1.6 years (18 months) of relevant work experience with a College diploma
- 1 year of previous relevant work experience with a Bachelor's degree
Education Level
- Minimum 3 years of College diploma (Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences, other Life Science.)
- Preferred 4 years of Bachelor’s degree (Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences, other Life Science.)
Salary/Compensations
- 48.02/hr
Benefits
- High-quality healthcare
- Prevention and wellness programs
About the Company
- 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.
- 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.
- 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 programs.
- Pursue progress, discover extraordinary.
- Better is out there. Better medications, better outcomes, better science.
- 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.
- At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
- Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
Equal Opportunity
- 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.
- At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.