Validation Manager, B100 – Vaccines
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.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Summary of Purpose:
Building 100, a new Vaccine manufacturing facility being constructed at Sanofi’s Toronto site, is an extremely exciting and complex project that will position Sanofi Pasteur on the cutting edge of the digital evolution of biopharmaceutical manufacturing. We are looking for two Validation Managers to join this team.
This position is responsible for providing expertise, quality oversight and guidance with regards to regulatory requirements and best practices related to manufacturing process equipment qualification, including computerized systems validation.
The candidate will participate in project workstreams, ensure proper execution of validation strategies as well as providing support for the quality processes and procedures. This individual will be working on cross functional project teams which include members from various organizations within Sanofi Pasteur, such as Bulk Manufacturing, Manufacturing Technology, Engineering and ITS
Management of Qualification and Validation:
- Provide quality oversight for manufacturing process equipment, CIP, SIP, Thermal, Utilities, HVAC qualification and computerized system validation activities pertaining to B100 licensure, start-up and lifecycle management.
- Review/approve validation deliverables (i.e. URS, specification documents, risk assessment, test strategies, protocols, executed raw data packages, reports, validation plans, SOPs, Equipment registration in SAP) in accordance with internal and regulatory policies.
- Review, assess and approve change controls, deviations and corrective plans, resulting from validation/qualification studies.
Support for Internal Compliance Activities:
- Keeps updated on new rules and industry regulations, and to define and align internal quality systems with best practices. Provide expertise and guidance with regards to regulatory requirements for manufacturing process systems qualification, as well as quality practices, validation strategies, procedures, and related validation activities.
- Responsible for identifying opportunity for improvements to quality processes through the review and evaluation of quality metrics and recommending appropriate resolutions.
- Bachelor’s Degree in Engineering / Science or related field
- 4+ years of experience in a GMP controlled environment/pharmaceutical industry is required.
- Experience with qualification of manufacturing process equipment (examples of manufacturing equipment include: Isolators, Fermenters, Microfiltration and Ultrafiltration systems, Centrifuges, Microplate Readers, etc.) required.
- Good understanding of current and evolving regulatory requirements required.
- Experience with computerized systems validation is preferred.
- Experience with qualification of Delta V, Data Historian OSI PI, and Manufacturing Execution System MES is preferred.
- Technical writing ability, effective oral and written communication skills, strong compliance mindset, good interpersonal and influencing skills are important for success in this role.
- Ability to anticipate evolutions due to internal and external factors beneficial.
- Familiarity with strategic planning, balanced judgment and risk analysis will be an asset.
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.
Sanofi, Empowering Life
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
To Apply, Click Here: http://bit.ly/386mf0b
Reference Number: R2573994
Type of Employment: Temporary – Full Time (1-year Contract)
Positions Open: 2
Department: Building 100 Validation
Location: Toronto, Ontario
Sanofi Pasteur: The world’s leading vaccine company