Manufacturing and Supply
Wo Wunder der Wissenschaft
für Patient*innen Realität werden

Reference No. R2801222

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

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. 

Directly manage and coordinate work with Lead Hand/team by assuring resources are planned and utilized efficiently and effectively to support R&D, QA/RA, Production and IO needs on Metrology activities across the Toronto plant.  Manage the Metrology work team by developing plans for staff to maximize current and future capacity requirements and by providing ongoing leadership and performance feedback to the various Metrology staff within Sanofi Pasteur Limited Toronto.  Maintain the Metrology/Calibration Program within the Facilities Management Division at a level that meets safety, regulatory compliance and/or applicable government guidelines and codes thus ensuring there is no loss of production or products.  Assist in the development/implementation of key documents (Project Plans, SOPs, and Standards) by providing technical recommendations (risk/benefit).

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing Progress to make a real impact on millions of patients around the world.

Main Responsibilities:

Responsible for the definition and application of site Metrology policy to be applied to GxP critical measuringdevices (20 %) 

• Participates in definition and development of Corporate Calibration Policy.  Ensures site specific constraints are taken into consideration.

• Translates corporate policy into site policies and procedures and ensures their application.  Presents and justifies impact of policy changes to Supply Chain Management Committee.

• Ensures that all key site personnel are appropriately trained and applying policies and procedures.

Develops and implements certification program for site (30 %)   

• Establish frequency and tolerances to be applied for certification on GxP critical devices.

• Ensure compliance with cGMP guidelines and regulations with respect to certification programs.

• Ensures equipment is maintained in certified status.  Any changes to equipment are reviewed and evaluated to ascertain whether additional studies, repairs and/or re-certifications are required.

• Ensure industry best practices are reflected in departments SOP’s.

Writes and reviews SOPs, certification protocols and reports as required (20 %) 

• Contributes to the writing of corporate policies for Metrology.

• Presents and justifies changes to site policies and procedures.

• Write and/or review standard operating procedures for equipment and procedures throughout the company with respect to metrology.

• Ensure that all departmental processes are covered by SOP’s and are maintained as current.

• Provides expert review of OQ (Operating Qualifications) protocols and reports as required.

Maintains the competency of department (10 %)

• Ensures department has skills and competence required to carry out certifications.

• Trains technical and users on how to apply Metrology principles.

• Maintains self-up to date on industry best practices.

Provides expert assistance in selection of equipment/instrument or troubleshooting (10 %)   

• Render expert assistance in troubleshooting certification and/or production failures linked to critical devices.

• Review equipment specification documents to ensure calibration constraints taken into consideration prior to purchase.

• Trains staff in root cause analysis as it pertains to critical devices.

Provides expert assistance in deviation and investigation (10 %)

• Support the leader of Investigation with deviations related to calibration.

• Write and/or review DCF

HSE Requirement/Statement:

Required language for all employees who have direct reports:

• Supervises and monitors compliance with employment and health and safety legislation to ensure that employees work within the policies, procedures and regulations applicable to their work.

• Participates in the investigation of incidents and work-related illnesses.

• Responds promptly to all health and safety concerns or incidents and completes the appropriate documentation in a timely manner.

• Takes every reasonable precaution to ensure the health and safety of staff.

• Ensures that protective equipment and clothing required is used by staff.

• Cooperates and assists the Joint Health and Safety Committee in carrying out its functions.

• Advises staff of any potential or actual health and safety hazard of which they are aware.

​

Required language if you do not have direct reports:

• Works within the policies, procedures and regulations as required by the Company and under the Occupational Health and Safety Act.

Dimensions/Scope:

• Responsible for Calibration of equipment and/or instruments at the Sanofi Pasteur Limited Toronto site. 

Budgetary Responsibility: 

• Manage an approved budget (>$500,000 and <$1,000,000)

• Purchasing Authority:   < $1,000

Key Decisions:

• Establishing Certification policy for the site.

• Prioritize/schedule maintenance work.

• Develop procedures for calibration certification for equipment and/or instruments.

• Evaluation of test data and results to ensure compliance.

• Evaluation of skills/competence of technical and/or contract staff performing calibrations.

• Decisions on acceptance or rejection of metrology work.

About You

Functional/Technical skills

• Must have an understanding of related profession/trades related to Metrology/Calibration – of  equipment, instruments and systems, along with an understanding of the various areas within the facility from the biotechnical production areas to the related support functions within the metrology department.  Evaluation of skills/competence of technical and/or contract staff performing calibrations. 

• Knowledge of metrology, calibration, testing and certification of equipment and instruments.

• Decisions on acceptance or rejection of metrology work and evaluation of test data and results to ensure compliance knowledge of cGMP Guidelines/Policies or compliance codes.  

• Ability to prepare and ensure that budget criteria’s are met.

Supervisory/Personal skills

• Ability to manage labor relations, closely liaison with all trades, production, R&D, QA/RA, Engineering, external contractors or consultants, and other site personnel as needed.  Personnel Management - Identify, co-ordinate, administer, and provide, technical training, as required for personnel. 

• Knowledge of any Federal and Corporate standards, policies or codes (i.e. Employment Standards Acts, Canadian Human Rights, Occupational Health and Safety Acts, Federal Contractor Program) related to metrology activities.

Key Requirements:

• A Bachelor of Science Degree or College Diploma with ASQ certification or ability to complete ASQ Certification within the first year of service.  

• A minimum of 5+ years' experience in a metrology, calibration, and/or quality function in a sophisticated manufacturing environment.

• Proven record as a both a Manager and Business Leader preferred

• Membership in Professional Association(s) related to this field (i.e. ASQ, PSG) preferred.

• Membership in Professional Association(s) related to this field (i.e. ASQ, PSG).

• Experience working with Microprocessor controlled equipment, multi-point Temperature Recorders, PLC’s and PID’s, temperature & pressure devices and calibration instruments and standards.

• In depth knowledge of metrology, calibration, testing and certification of equipment and instruments.

• Statistical Analysis: Ability to conduct trend analysis, interpretations of data so as to show meaningful results of study.

• Scientific report writing techniques to include: writing SOP’s, protocols, monthly reports etc.

• Excellent written and verbal communication skills.

• Interpersonal skills and ability to function as part of a team while motivating technical staff to achieve results.

• Ability to negotiate with users to best define process and instrument tolerances.

• Problem solving skills with ability to identify root cause of certification failures or trends.

• Organizational skills to create a department that is at optimal productivity and consistently look to increase efficiency.

• Experience working with Calibration Software

• Experience working with Autoclaves, Ovens and Fermentors.

• Training in cGMP guidelines.

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

This position is for a current vacant role that we are actively hiring for.

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.

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.

Diversity und Inklusion sind in den Grundwerten von Sanofi verankert und spiegeln sich in unserer Arbeitsweise wider. Wir respektieren die Vielfalt unserer Belegschaft in Hinsicht auf ihre Herkunft, Erfahrungen und Lebensweisen. Wir erkennen die Bereicherung, die diese Vielfalt birgt, und fördern Inklusion sowie eine Arbeitsumgebung, in der diese Unterschiede sich weiter entwickeln können, zur Stärkung des Lebens unserer Mitarbeiter, Patienten und Kunden.