[Janssen/Quality] Microbiologist（Quality Control Group, Fuji Plant）

• Perform microbiological sampling and testing for raw material, semi-finished products, finished products, water testing and environmental monitoring in a timely manner as per procedures. • Review, evaluate and investigate results from various analysis. • Accountable for identifying trends and reoccurring issues and take action to mitigate. • Review documentation for testing activities to ensure it is accurate and complete. • Be a team lead to provide direction and guidance in problem solving, troubleshooting and documentation related to laboratory investigations. • Participate and/or lead in special projects such as laboratory equipment validation, test method transfers, process improvements, and document change orders. This will include writing, updating and executing study protocol. • Lead, assist, and train others in laboratory functions, especially more complex functions. • Ensure the development and implementation of new or proven technology. • Represent laboratory in internal and external audits. • Lead and/or help supervisor to promote continuous improvement in laboratory areas, especially surrounding Lean principles. • Network and benchmark across J&J and the industry for best in class processes and equipment. • Serve as an innovation mentor. • Assist support in laboratory manpower planning, and to assign work to other laboratory personnel. • Perform other work-related activities assigned by Supervisor. Qualifications Qualification • Bachelorʼs Degree in Biology, Biochemistry, Microbiology or related field. • At least 5 years related experience in biopharmaceutical or pharmaceutical industry. And/or an equivalent combination of education and experience. • Advanced knowledge and experience with regulatory requirements, policies and guidelines. • Significant experience with Quality Control document reviews and regulatory inspection processes. Other Requirements • Compliance with the GMP, EHS, WWRIM, AE/PQC, IAPP and other local legal and/or regulatory requirements. *Johnson & Johnson Family of Companies in Japan strongly recommends prospective employees to complete the COVID-19 vaccination before or as soon as after joining our company to prevent the spread of infection among our employees and people around them as well as our customers and the community we serve, and to ensure our responsibilities are sustainably fulfilled as a healthcare company (except for those who cannot vaccinated with underlying medical conditions and other circumstances). Primary Location Japan-Shizuoka-Ken-Fuji- Organization Janssen Pharmaceutical K.K. (7195) Job Function Quality Requisition ID 2206018993W