Cleaning Validation Manager- Toronto/ON
- Develop strategy, plan and execute activities related to cleaning process development, cleaning process validation, cleaning process improvement and implementation for NV and PPI projects. T
- he job is related to compliance, efficacy, quality and safety.
- Design, plan and execute experiments to demonstrate robustness, optimize processes, efficiency of cleaning processes with the goal of product quality and safety.
- Maintain the validated status of cleaning processes.
- Perform routine verification studies.
- Audit current cleaning processes and ensure compliance with cGMP, site/global quality guidelines and current industry standards.
Manage and coordinate the Cleaning Validation Team, including technologist(s) and contractor(s).
Coordinate activities with staff performing executions from Production and BRD/ARD.
Train and mentor personnel. (10%)
Interact with cross functional teams in Production, BRD/ARD, Quality Operations and other internal and external groups (France and USA) to support process development, process improvement and validation. (10%)
Participate in NV, PPI, MAR and INF project teams, working groups and task forces (local and or global).
Responsible for scientific and technical aspects of assigned projects and activities (15%)
Design, plan and execute studies to demonstrate robustness, optimize processes, efficiency of cleaning processes with the goal of product quality and safety. (15%)
Generate validation protocols, risk assessments and supportive developmental studies for cleaning processes. (25%)
Generate reports for cleaning process validation, and technical reports for specific projects (20%)
Support and comply with all Sanofi Pasteur health, safety and environmental policies, contribute toward meeting departmental/platform goals; and demonstrate progress in preventing or reducing injuries and/or illness (5%)
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.
Hours of Work: Monday to Friday: 8:00 – 4:00 p.m.
- Bachelor's degree in Pharmaceutical or Biological Sciences, or Chemical Engineering, with 5 - 7 years relevant experience; OR
- Masters degree in Pharmaceutical or Biological Sciences, or Chemical Engineering, with 3-5 years relevant experience;
- 3 years of experience in manufacturing
- An in-depth knowledge of technical areas specific to cleaning processes is required (Cleaning Process Design & Development, Residues & Limits, Sampling & Markers, Analytical Methods).
- An in-depth knowledge of technical areas specific to manufacturing processes is required (Formulation, Protein Chemistry, Scale-up, Cell & Viral Culture, Adjuvants) .
- Candidate should possess a familiarity with Regulatory Requirements, a working knowledge of Project Management , Statistical Process Control (SPC) skills and Six Sigma methodology.
- The position requires additional specific competencies: exp: ability to think strategically, lead teams, develop people, make decisions.
Sanofi Pasteur: The world’s leading vaccine company
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.
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.
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