Professional Commissioning & Qualifications
Genzyme
Toronto, ON
10d ago

Professional Commissioning & Qualifications

Reference : #R637

Location : Sanofi Pasteur Limited / North York, Ontario

Department : Toronto / Site Technical Services

Required Education : Degree in Applied Science or Engineering

Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines.

Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines.

Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe.

Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases.

Position Summary :

The Professional for Commissioning and Qualification (C&Q) is responsible for the administration of the Commissioning and Qualification activities at the Toronto manufacturing site.

This position will report to the Manager, C&Q and will be a key contributor to the Site Engineering team. The Professional C&Q will work closely with key stakeholders in a variety of departments within the manufacturing sites to assure all design changes, commissioning needs, and operational support requirements are met.

Main Responsibilities

  • Act as primary C&Q interface with Project Management and Quality functions.
  • Lead the use of the site C&Q Program and ensure alignment with Sanofi Pasteur’s corporate standards along with engineering best practices.
  • Be responsible for the management, mentoring and development of C&Q staff along with the C&Q Manager
  • Lead development, approval, execution, resolution and reporting of all project specific engineering C&Q documentation.
  • Responsible for project documentation management and quality of the Engineering Turnover Documentation.
  • Responsible for administration of training for site commissioning and qualification methods to execution team.
  • Responsible for managing commissioning and qualification phase advancement.
  • Monitor / evaluate contractor safety performance throughout the duration of the project.
  • Provide oversight to project contractors to ensure Site C&Q Program methods are being utilized per procedures.
  • This individual should be a self-starter with strong interpersonal, organizational, and technical skills. Capability to work both independently and in a team environment.
  • Strong analytical and communications skills are required.

  • Excellent written and verbal presentation skills to support interactions with engineering management are required.
  • Strong mentoring and development experience is required.
  • Must be able to establish strong working relationships with stakeholders (Quality, Manufacturing, and MTech) to ensure high quality deliverables meeting CGMP and site quality requirements.
  • Position Summary :

    The Professional for Commissioning and Qualification (C&Q) is responsible for the administration of the Commissioning and Qualification activities at the Toronto manufacturing site.

    This position will report to the Manager, C&Q and will be a key contributor to the Site Engineering team. The Professional C&Q will work closely with key stakeholders in a variety of departments within the manufacturing sites to assure all design changes, commissioning needs, and operational support requirements are met.

    Main Responsibilities

  • Act as primary C&Q interface with Project Management and Quality functions.
  • Lead the use of the site C&Q Program and ensure alignment with Sanofi Pasteur’s corporate standards along with engineering best practices.
  • Be responsible for the management, mentoring and development of C&Q staff along with the C&Q Manager
  • Lead development, approval, execution, resolution and reporting of all project specific engineering C&Q documentation.
  • Responsible for project documentation management and quality of the Engineering Turnover Documentation.
  • Responsible for administration of training for site commissioning and qualification methods to execution team.
  • Responsible for managing commissioning and qualification phase advancement.
  • Monitor / evaluate contractor safety performance throughout the duration of the project.
  • Provide oversight to project contractors to ensure Site C&Q Program methods are being utilized per procedures.
  • This individual should be a self-starter with strong interpersonal, organizational, and technical skills. Capability to work both independently and in a team environment.
  • Strong analytical and communications skills are required.

  • Excellent written and verbal presentation skills to support interactions with engineering management are required.
  • Strong mentoring and development experience is required.
  • Must be able to establish strong working relationships with stakeholders (Quality, Manufacturing, and MTech) to ensure high quality deliverables meeting CGMP and site quality requirements.
  • Hours of Work :

    Monday to Friday 8 : 00a.m.-4 : 00p.m.

    Sanofi Pasteur Canada embraces diversity in the workplace and is committed to achieving employment equity. 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 applications from women, members of visible minorities, Aboriginal peoples and persons with disabilities.

    Thank you in advance for your interest.

    Only those candidates selected for interviews will be contacted.

    We are an equal opportunity employer.

    MON-SC

    Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs.

    Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.

    At Sanofi, our ambition is to be an integrated global healthcare company, focused on patients’ needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world.

    We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.

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