Staff Scientist – Microbiology & Sterility Assurance (Supplier / External Manufacturing)

Supporting end‑to‑end Microbiological Quality & Sterility Assurance (MQ&SA;) activities related to suppliers and external manufacturing processes. Contributing to change requests and projects impacting controlled environments, cleaning, and sterilization processes. Supporting contamination control strategies, including environmental monitoring and investigation activities. Providing technical guidance and training on microbiological quality and sterility assurance. Acting as subject matter expert for investigations, CAPA, non‑conformances, audit observations, and risk assessments. Supporting due diligence activities (e.g., acquisitions, partnerships) by providing MQ&SA; expertise and risk input. Supporting development and updates of supplier quality agreements. Coordinating and participating in supplier audits, including preparation, on‑site support, response review, and follow‑up activities. Partnering with cross‑functional teams to support supplier qualification and lifecycle management. Contributing to remediation activities following audits or regulatory findings. Building strong relationships with external partners, including manufacturers, suppliers, sterilization providers, and testing laboratories. Coaching and supporting colleagues and partners in MQ&SA; practices.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

• Bachelor’s degree in Microbiology, Biological Sciences, Engineering, or a related field

• At least 6 years of experience in microbiology and sterilization assurance within the medical device or pharmaceutical industry

• Strong knowledge of microbiological control, contamination control, and sterilization processes

• Familiarity with applicable standards and regulations (e.g., ISO, EN, AAMI)

• Experience conducting or supporting investigations, test method development, and validation

• Knowledge of regulatory and quality requirements related to suppliers and external manufacturing

• Experience supporting audits, inspections, or compliance assessments

• Strong communication and collaboration skills, with the ability to work across functions and levels

• Ability to work independently while contributing effectively to team objectives

• Fluent in English (French and/or German are a plus)

• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity