Technologist- Vaccines

Job type: Full-Time
Accepting BioReady™: Yes
Category: Clinical Research
Education: Bachelor
Experience: 0-3 Years
Employer: Sanofi
Location: Toronto, ON
Posted: March 28, 2024
Closes: April 28, 2024

Reference No: R2736403

Department: Formulations

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:

  • FORMULATIONOFINTERMEDIATEANDFINALBULKPRODUCT:
  • Prepare and execute BPRs for intermediate and final bulk manufacturing, including both manual and computer-based calculations.
  • Release process orders, prepare sample labels, complete documentation and prepare/release equipment and tanks necessary to perform a formulation.
  • Perform routine formulations activities in classified environment (classification C-1/C/D) using closed system technology (e.g tube welder, tube sealer), procedural clean room behavior and monitoring requirements (e.g Met-one, MAS, etc)
  • Preparation, disinfection of materials and equipment, and disinfection of room before and after completion of formulations activities.
  • Tank inspection, preparation and release.
  • Perform filter integrity testing on multiple types of filters.
  • Perform dilution, pooling, filtration, transfer of bulk materials.
  • Perform tank preparation (e.g. pressurization, routine stirring) for storage and/or shipping.
  • Check incoming or outgoing tanks and equipment for integrity, breaches, anomalies, mixers and acceptance.
  • Preparation and review of detailed calculations for formulation of intermediate and final bulk vaccines using antigens and excipients following related BPRs (~25) and SOPs (-80).
  • Perform entry of test samples and environmental monitoring samples in appropriate computer program (e.g.LIMS, EM tracking programs,  etc)
  • Perform SAP confirmation of activities.
  • Perform BPR entries into BPR and database.

PRODUCTIONAREA MAINTENANCE, PARTS ANDINVENTORIES:

  • Perform routine facility cleaning and disinfection as required per SOP (e.g daily, monthly, quarterly and non-routinely as required)
  • Preparation of rooms (including clean rooms) for formulation, sampling and environmental monitoring (e.g. daily routine, post shutdown activities).
  • Prepare and sample environmental monitoring as outlined by procedures.
  • Monitor and perform EM as required per product, per week, per bi-weekly, per month. Includes data entry for processing of samples.
  • Delivery of EM samples.
  • Verification of routine facility EM, Utility (e.g. WFI/Compressed air) schedules independent to the production requirements.
  • Perform routine maintenance of scales, pH meter, tube welder and sealer.
  • Prepare and receive equipment coming to and from maintenance.
  • Perform inspection of released equipment prior to use.
  • Co-ordinate and receive items from dock/shipping area(including antigen, media, consumables as required).

B92 PLATFORMSUPPORT ACTIVITIES:

  • Support to B92 Platform as required and based on supply chain demand requirements (e.g. in times of low demand for routine formulation work).  This may include:
  • Supporting routine and non-routine environmental monitoring requirements for production areas and utility systems including common shared areas, compressed air/WFI (e.g. hallways, refrigerators, etc).
  • Support project protocol executions for the platform as needed.
  • Support execution of routine re-qualification activities for the B92
  • Platform (e.g. ISO classification requalification)
  • Supporting document update, batch design/review
  • Support B 100 Interim Powder Dispensing based on supply chain demand requirements (including execution of dispensing, support of storage/delivery).

EQUIPMENTPREPARATIONANDOFFICEDUTIES:

  • Enter data into logbooks, electronic data collection (e.g.  SPC/shop floor data, sharepoints, etc).
  • File completed documents and logbooks.
  • Maintain inventory of laboratory and office supplies.
  • Maintain and ensure 5S of supplies, material and equipment.
  • Assist with review of documents (e.g. procedures, BPRs) and protocols for execution.

TRAINING:

  • Plan and complete personal training; attend team training to ensure cGMP.
  • compliance, including protocol training, re-training as required.
  • Maintain training completion at >98%.
  • Demonstrate and exhibit understanding and compliance of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Data Integrity training to avoid non-compliance issues.    Maintain update training as required.
  • Support training of new operators and other team members as required.

ASEPTICPROCESS SIMULATION STUDIES:

  • Prepare documentation/labels, equipment, media availability for Aseptic Process Simulation Studies (APSS) to ensure execution of APSS meets schedule.
  • Complete protocol training and ensure understanding of requirements for execution.
  • Execute routine Aseptic Process Simulation Studies as per protocol.
  • 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 operations.

Minimum Qualifications:

  • Minimum three (3) years Bioscience, Pharmaceutical Technology College degree (Biotechnology, Microbiology, Technologist Program), plus a minimum of two (2) years previous relevant work experience.
  • Preferred four (4) years Accredited University degree, Bachelor of Science, BioScience (Biological Science, Chemistry, Pharmaceutic al Technology), plus a minimum of one (1) year of previous relevant work experience.
  • Closed system Technology/Aseptic Technique, Environmental Monitoring equipment and practices
  • Sterile Filtration/Sterile Filters/Filter testing
  • GMP, GDP and Data Integrity regulatory requirements
  • Computer Skills, SAP, LIMS, EM tracking programs, Shopfloor Data
  • Organization/Planning Skills
  • Written/Oral Communication Skills

Hours Of Work:

Inclusive from Monday to Friday 6:00 am- 2:00 pm.

This is subject to change at any time, and it should not be construed as limiting the right of the company to make such change to meet the requirements of the operation.

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 www.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.

Follow Sanofi on Twitter: @SanofiCanada  and on LinkedIn: https://www.linkedin.com/company/sanofi

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