Reference no. R2855279
Position title: Aseptic Processing Professional
Department: FFIP Pandemic Flu Filling
Location: Toronto, ON
Fixed Term; 12/24/2027
About the Job
Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.
This role will manage projects affecting the Filling platform in relation to compliance and continuous improvement projects. This role will also act as a technical resource person who uses cleanroom and aseptic processing knowledge to work within Sanofi manufacturing and Quality Systems to support Filling in the context of change control lead, CAPA owner, SME for global projects, and regulatory audits.
About Sanofi
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.
Main Responsibilities:
Technical Writing (70%)
Prepare and update GMP documents such as SOPs, SWIs, protocols, reports.
Assist in maintaining GMP documents to meet compliance standards and alignment with Global Quality Directives.
Participate/oversee implementation of component specification documents.
Quality/ Project Management Support (15%)
Provide project management support on compliance related activities and continuous improvement projects specific to Filling, with the aim to close gaps within the required timeframe and ensure minimal impact to production activities.
Filling representative for Site Wide Initiatives/ Continuous Improvement projects related to Quality Systems, Processes and Procedures.
Perform and/or participate in GQD gap analysis for the Filling Department.
Implements Corrective and Preventative Actions established as Filling commitments in response to Internal/ Global or Regulatory Audits.
Identify opportunities for alignment across the IO platforms or within Filling, applying LEAN methodologies.
Coordinate the media (broth) simulation operation: by working with QOSA review broth protocols, communicate and serve as liaison between the two departments; work with shift managers and filling group leaders to ensure successful completion of the media simulation study.
Support the Environmental Monitoring (EM) program: coordinate policy and SOP updates and implementation; provide and conduct staff training; conduct weekly FMS review.
Serve as coordinator with other service provider departments, such as, Metrology, Facilities, External vendors, etc., and support the shift managers with operational activities (ex. Annual instrument calibration, etc.).
Assist in routine revalidation/non-routine validation activities such as autoclave revalidation, smoke studies, ISO Re-Certification etc. with QOVS, Thermal, QOSA. Review and approve related protocols.
EM FFaST Lead: Conduct monthly discussion forum for EM Trends, EM Deviations, improvements that can help improve EM trends in controlled areas. Review and approve EM trend reports. Coordinate with QOSA to implement CAPA and GQD updates to area specific tasks.
Develop training plan and maintain training database for new and existing employees to ensure all operators are qualified for required job tasks.
Hold training sessions to ensure operators understand changes to existing procedures as well as the implementation of new procedures, and to field clarifying questions or concerns from staff.
Role of system administrator for various production stand-alone equipment.
Change Control Lead (15%)
Initiate and manage change control requests affecting the Filling Department.
Collaborate with assessors for evaluation of changes.
Ensure timely closure of change controls.
Support Lead Investigators and Filling Platform in establishing change controls approved for execution in a very short timeframe to support closure of Quality Notifications.
This position may require travel within Canada and globally.
About You
Education and Experience:
Bachelor’s degree in Science / Engineering or in a related field with 1 -3 years of experience.
Efficiently use company tools such as SAP, QualiPSO, Pharmnet Web, MASTER, Phenix, RapidPharma, Procal, Regulus etc., and the ability to adapt to new tools
Strong interpersonal skills.
Strong verbal and written communication skills
Hours Of Work:
-
Be flexible to work Morning or Afternoon (Subject to change).
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.
Why Choose Us?
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
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.
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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Toute compensation sera déterminée en fonction de l'expérience démontrée. Les employés peuvent être admissibles à participer aux programmes d'avantages sociaux de l'entreprise. Des informations supplémentaires sur les avantages sociaux peuvent être trouvées ici.
