Cleaning Validation Manager- Vaccines
Synthorx
R2819412 Cleaning Validation Manager- Vaccines
Department: Cleaning validation
Duration: 4 months
Location: Toronto, ON
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 Cleaning Validation Manager will be to:
Manage and coordinate Cleaning Validation activities.
Develop strategy, plan, and execute activities related to cleaning process development, cleaning process validation, cleaning process monitoring/verification, cleaning process improvement and implementation for new and existing processes.
The 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.
Audit current cleaning processes and ensure compliance with cGMP, site/global quality guidelines and current industry standards.
We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.
Main Responsibilities:
Lead and coordinate cleaning validation activities across multiple manufacturing facilities (Legacy space/B100/B200), including development, verification, monitoring, and compliance.
Develop comprehensive strategies, protocols, and execute validation studies to ensure cleaning process effectiveness, robustness, and regulatory compliance.
Generate technical documentation including risk assessments, validation protocols/reports, method validation documents, and SOPs for cleaning processes.
Design and execute studies to optimize cleaning processes, focusing on product quality, safety, and efficiency improvements.
Provide technical expertise during investigations of non-conformances/deviations and support internal/regulatory audits as Subject Matter Expert.
Collaborate with cross-functional teams (Production, Quality, Labs) and external partners to support process development, improvement, and validation activities.
Train and mentor personnel on cleaning validation principles, protocols, and study execution while ensuring compliance with Sanofi policies and regulatory standards.
Drive continuous improvement through evaluation of cleaning processes, implementation of Lean Management Systems, and identification of efficiency opportunities.
About You
Bachelor's degree with 2-3 years of relevant experience OR Master's degree with 1+ years of relevant experience.
In-depth knowledge of cleaning processes including design, development, residue limits, sampling methods, and analytical techniques.
Familiarity with regulatory requirements and experience in pharmaceutical manufacturing environments.
Strong analytical skills with systematic problem-solving abilities and attention to detail.
Project management experience with knowledge of Statistical Process Control (SPC) and Six Sigma methodology preferred.
Understanding of manufacturing processes (fermentation, purification, formulation) is an asset, particularly in vaccine production environments.
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
This position is for a new vacant role that we are actively hiring for.
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.
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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 and check out our Diversity Equity and Inclusion actions at sanofi.com!
North America Applicants Only
The salary range for this position is:
$76,200.00 - $127,000.00All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
La fourchette salariale pour ce poste est la suivante:
$76,200.00 - $127,000.00Toute compensation sera déterminée en fonction de l'expérience démontrée. Les employés peuvent être admissibles à participer aux programmes d'avantages sociau de l'enterprise. Des informations supplémentaires sur les avantages sont disponibles via le lien.