**Reference No.** R2780597 **Position Title:** Sample Manager, Cleaning Validation **Department:** Cleaning validation **Location:** Toronto, Ontario **Duration:** 8 months contract **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. Your job, as Sample Manager, Cleaning Validation within our Cleaning validation team will be to Manage and coordinate the Cleaning Validation sampling activities, including sample estimation, delivery, sample tracking, sample documentations, testing confirmation, result availability and overall sample reconciliation. Develop strategy, plan, and execute activities related to sample management of cleaning process development, cleaning process validation, cleaning process monitoring/verification and cleaning process improvement. The job is related to compliance, efficacy, quality, and safety. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? **Main Responsibilities:** **Management (55%)** + Manage and coordinate the Cleaning Validation\Verification\Monitoring sample management activities. + Train and mentor personnel. + Ensure compliance to all Sanofi policies/procedures (including HSE), regulatory standards, and validation master plans. + Coordinate the sampling activities of cleaning development, verification, validation, continuous monitoring, and other relevant activities. + Ensure that sample requests are created, sampling labels created, samples delivered and tested in a timely manner. + Functions as the point of contact between the testing labs and the cleaning validation/verification/monitoring project stakeholders + Ensure that the inventory of consumables and materials required for studies is adequately maintained. **Provide Technical Support (10%)** + Support any investigation of non-conformances/deviations encountered during the execution of cleaning validations/continuous monitoring/verification activities. + Write or review/approve technical/quality system documents such as SOPs, Study protocols/Reports, Change Controls, Deviation Investigation Reports, Batch Production Records, as they relate to cleaning validation, cleaning monitoring and regulatory compliance. **Co-operate Transversally (30%)** + Interact with cross functional teams in Production, Quality Operations, testing labs and other internal and external groups to support process development, process improvement and validation. + Consult with internal and external testing labs in relation to the testing of samples for cleaning development/validation/verification/monitoring. + Participate in relevant project teams, working groups and task forces. **Continuous Process Improvement (3-5 %)** + Evaluate cleaning SOPs, validation SOPs, and initiate process improvements, as necessary. + Participate and enhance established ways of working on the management of cleaning validation/verification/monitoring samples, ensuring continuous improvement and process efficiency. **HSE REQUIREMENT/STATEMENT** + 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 + 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. **CONTEXT OF THE JOB/MAJOR CHALLENGES** + Office environment: 35 hours a week with occasional visit to the labs and shop floor + Drive cross-functional alignment. + Support the culture of pro-activeness for the management of industrial processes. + Participate in continuous improvement in the process industrialization within MSAT. **DIMENSIONS/SCOPE** + Breadth of responsibility (global/regional/country/site): Toronto, Canada + Key dimensions: large biopharmaceutical facility, with extensive scope and complexity in facility/process design and qualification, process improvement implementation; effective cross-functional interaction, communication, and team management + Freedom to act, level of autonomy: interface with function heads; project leaders; experts/SPPs; process validation teams, internal and external testing labs **About You** **REQUIREMENTS** **Education/Certifications/Experience** + Bachelor’s or master’s degree in sciences or engineering, with 1+ years of relevant experience in pharmaceutical manufacturing, sample management, and project management/co-ordination. + Knowledge of technical areas specific to cleaning processes (Cleaning Process Design & Development, Residues & Limits, Sampling & Markers, Analytical Methods) is considered an asset. + Knowledge of technical areas specific to manufacturing processes (e.g Fermentation, Harvest and Purification, Adsorption, Formulation, Scale-up, Cell & Viral Culture, Adjuvants) is considered an asset. + Sound knowledge of Project Management including project co-ordination, stakeholder management and excellent communication skills. + Proficiency with Microsoft excel and/or programming is an asset. + Excellent analytical skills, with systematic approaches to problem solving and high level of proactiveness is required. + The position requires additional specific competencies: exp: ability to think strategically, lead teams, and make decisions. **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 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. \#GD-SP ​ \#LI-SP \#LI-Onsite **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! 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. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)