Sterility Assurance and Microbiology Specialist

Sterility Assurance And Microbiology Specialist

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.

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

• Serve as subject matter expert for contamination control, aseptic processes, and sterility assurance programs including process simulations, traffic patterns, gowning procedures, and disinfection protocols.
• Conduct comprehensive risk assessments related to contamination control and develop mitigation strategies to ensure product quality and patient safety.
• Monitor site activities and performance metrics for contamination control systems, ensuring compliance with procedures through regular shop floor presence and GEMBA walks.
• Lead investigations following contamination control failures, propose effective corrective and preventive actions (CAPA), and implement sustainable solutions.
• Advise teams on sterility assurance best practices, participate in global Centers of Excellence, and implement shared best practices at the site level. Review contamination control monitoring data to identify trends, propose process improvements, and optimize sterility assurance systems.
• Author, update, and approve departmental documents including SOPs, protocols, reports, and training materials to ensure regulatory compliance.
• Participate in regulatory inspections and audits, presenting and defending materials related to sterility assurance and microbiology with technical expertise.
• Mentor team members on aseptic manufacturing processes and facility design, contributing to the development of technical capabilities within the organization.

About You

• Bachelor's degree required; science or engineering fields strongly preferred.
• Minimum 5 years of experience in cGMP-controlled pharmaceutical or vaccine manufacturing environment with demonstrated knowledge of regulatory requirements and Good Manufacturing Practices.
• Expertise in topics related to contamination control, aseptic processes, and sterility assurance programs including process simulations, traffic patterns, gowning procedures, and/or disinfection protocols.
• Ability to meticulously review and analyze documentation, processes, and products to ensure compliance with regulatory standards and Sanofi Quality requirements.
• Strong communication skills to effectively interact across all organizational levels (shop floor to management) and present complex technical subjects to diverse audiences.
• Demonstrated ability to organize and lead multi-disciplinary investigations with strong problem-solving capabilities and implementation of effective.

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 and at least 14 weeks' gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.