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:** Quality **Job Sub** **Function:** R&D/Scientific Quality **Job Category:** Professional **All Job Posting Locations:** Memphis, Tennessee, United States of America **Job Description:** Johnson & Johnson is recruiting a **Microbiology Quality & Sterility Assurance, Scientist** , located in **Memphis, Tennessee.** **_A pre-identified candidate for consideration has been identified. However, all applications will be considered._** **About MedTech** Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech Microbiological Quality & Sterility Assurance (MQSA), Scientist position is responsible for end-to-end implementation of strategic projects associated with microbiological quality and sterility assurance across the make/deliver and product development teams for Orthopedics and will ensure that those programs are aligned with the overall J&J Microbiological Quality & Sterility Assurance programs. The Scientist, MQSA, Quality Management will serve as a technical leader in the areas of microbiological quality, sterilization, and reprocessing. He/she partners to centrally support other product development and product manufacturing teams. He/she sets is the subject matter expert for the site through the application of technical knowledge and expertise in microbiological quality, and sterilization processing. The position will be responsible for product development and make and direct support for the Deliver Quality organization. This position is responsible for compliance with applicable quality regulations and standards and serves as the site point of contact for MQSA. **Key Responsibilities:** + Lead the integration of MQSA policies and procedures at the site. + Lead the design of new manufacturing processes, controlled environments and packaging for microbiological quality, terminal sterilization and reprocessing. + Maintain knowledge of best practices, standards and guidance in sterilization, processing, aseptic technique and environmental monitoring. Ensure policies and procedures are maintained to ensure compliance. + Support all compliance audits, including points of contact for strategic collaborations. + Lead opportunities for business continuity planning for sterilization and contamination prevention across GO + Identifies internal and external opportunities to influence best practices in sterility assurance and microbiological quality by interacting with regulators, standard/guideline organizations, research and academic institutions. **Qualifications** **Education:** + University/Bachelors or equivalent degree with Microbiology, Biology, Engineering or related discipline is required. **Experience and Skills:** **Required:** + A minimum of two (2) years of related experience in a medical device and/or pharmaceutical industry in a GMP and/or ISO regulated environment. + Competent in using computer software such as Excel, Word and PowerPoint, and analytical software. + Experience in Microbiology, Sterilization Validation (terminal, aseptic, and/or reprocessing) and Environmental Controls for a medical device or pharmaceutical manufacturing facility. + Must have a strong understanding of product design, quality and manufacturing processes. + Proven track record on troubleshooting processes, non-conformances, out of specification test results, and providing resolution to issues by a robust CAPA process. + Experience in interacting with Regulatory Authorities + Knowledge of standards including EU, USA and ISO. + Strong teamwork and communication skills to work effectively on cross-functional project teams, interacting with a diversity of disciplines such as R & D, Packaging Engineering, Quality Engineering, Regulatory Affairs, Marketing, etc. + Independent organizational and time management skills. + Experience with conducting technical assessments of in-house and external manufacturing and terminal sterilization. **Other:** + Proficiency in the English language (oral and written) is required. + Up to 20% domestic or international travel is required. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.