Manager, Validation (Process) 2 year contract
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Reference #: R2561944
Position Title: Manager, Validation (Validation) (2 year Fixed Term Contract)
Hours of Work: Monday to Friday: 8:00 – 4:00 p.m.
Site/Department: Toronto, Ontario / Process Validation
This position is responsible for the development and execution of validation protocols and the review and approvals of validation documentation in accordance with internal and regulatory policies. The person in this role will represent the department, where applicable, on projects and provides technical expertise to multidisciplinary validation working groups, including change control assessment. This position involves the management and execution of a site validation master plan and the review and approval of all validation protocols and resultant reports. Validation status is then maintained through participation of a change control process identifying appropriate re-validation where appropriate.
To review and approve validation protocols and reports within the Quality Operations Department of Sanofi Pasteur Ltd Canada.
Represent the department on projects/assignments and on selected teams as defined by manager.
Reports Validation status linked to change controls and validation metrics.
Involved in training and department related activities.
Support process validation activities throughout the product lifecycle.
Review and approve protocols required to complete validation of manufacturing processes. May also support validation activities related to cleaning processes or test methods as required.
Responsible for working with user/system owner to perform validation (s) as per designated validation protocols and to critically evaluate the results to determine if they adequately meet the acceptance criteria. Be able to describe the methods required, provide the acceptance criteria and include a rationale for these choices.
Serve as Quality contact on Project Working teams as defined by supervisor in support of new and existing validation projects. Provide Validation Compliance support to initiatives related to routine manufacturing operations and where applicable other internal groups.
Support investigations linked to manufacturing and when required, support the response to technical questions.
Serve as QO designate in the review and approval of change controls.
Update and revision of departmental and company policy/procedures related to validation.
Develop and maintain site policies including support to Site Plans that describe validation initiatives aligned to regulatory requirements and global Quality and Industry standards.
Represent Quality on key company projects to ensure project deliverables are attained from a validation perspective.
Education and Experience:
A Bachelors degree in Chemical Engineering, Biology, Biochemistry, or Life Sciences combined with 3 years of work experience within validation the biopharmaceutical/pharma industry
In-depth knowledge of the principle discipline- validation and biopharmaceutical industry compliance (i.e. cGXPs, current industry standards and practices, and process/environmental engineering)
Working knowledge of Microbiology, Biochemistry, Chemical Engineering, Fermentation, Cell and Viral Culture, and Formulation & Stability
In depth knowledge of experimental work and data analysis
Working knowledge and hands-on experience with computer and statistical skills, scientific writing, supervision/management of teams and people (and their development), effective oral and written communication skills, and innovative thinking
Familiarity with strategic planning, balanced judgment and risk analysis
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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