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. Learn more at https://www.jnj.com **Job Function:** Non-Standard **Job Sub** **Function:** Workday Associate B **Job Category:** Non-Standard **All Job Posting Locations:** Beerse, Antwerp, Belgium **Job Description:** **In the R&D Microbiology Centre of Excellence (Beerse, Antwerp, Belgium) there is currently a full-time opening** **for a microbiology analyst conducting microbial method development, GMP method qualification/validation, and release and stability testing in support of the clinical development portfolio.** **R&D Microbiology Analyst** **Your Function** + Execute method development and GMP method qualification/validation for a diverse range of microbial assays, such as bioburden testing, bacterial endotoxin testing, sterility testing, etc.; + Perform release and stability testing on clinical products; + Coordinate and execute Low Endotoxin Recovery (LER) studies; + Coordinate and execute Microbial Challenge studies to determine hold time of sterile preparations; + Author, review and approve development reports, qualification/validation reports and test method descriptions; + Coordinate laboratory investigations; + Ensure compliance with regulatory requirements, GMP and safety. **Your Profile** + Bachelor’s degree in Biomedical Laboratory Technology, or equivalent through experience; + Good knowledge of and experience with aseptic and microbiological techniques; + Experience with GMP; + Meet high quality standards when executing experiments; + Efficient, flexible and dynamic. Capable of dealing with changes in the planning; + Team player yet able to organize and execute the work independently; + Demonstrate sense of urgency; + Good knowledge of English, both spoken and written. You will be welcomed in a diverse and coherent team, and will receive proper training by experienced analysts in order to fulfill your role. **Departmental responsibilities** As part of Johnson & Johnson Innovative Medicine, R&D - Discovery, Product Development, and Supply (DPDS) – Analytical Development (AD), the Microbiology CoE has the following responsibilities: + Providing global support for all microbiology-related aspects during clinical development (R&D) and life cycle management (commercial) of the J&J Innovative Medicine product portfolio (Biotherapeutics and Synthetics). + Coordinating microbial method development, validation/qualification and transfer activities with internal and external microbiology laboratories. + Microbial specification setting and control strategy. + Microbial risk assessments and investigation support. + Supporting regulatory inquiries in the field of microbiology. Validation and implementation of innovative microbial technologies for established and new product platforms.