Microbiology Quality & Sterility Assurance Scientist

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 jnj.com . 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. Job Function: Quality Job Sub Function: R&D/Scientific Quality Job Category: Professional All Job Posting Locations: Warsaw, Indiana, United States of America Job Description: Depuy Synthes a member of the Johnson & Johnson Family of Companies is currently recruiting for a Microbiology Quality & Sterility Assurance Scientist! This position will be located in Warsaw, IN.

Summary The Laboratory Technician is responsible for performing microbiological, environmental monitoring, and analytical testing activities that support medical device development, manufacturing, contamination control, and validation programs. The position operates in a regulated laboratory environment and performs testing in accordance with approved procedures, protocols, work instructions, and applicable regulatory requirements. The Laboratory Technician will conduct microbiological analyses, prepare laboratory media and reagents, support reusable device validation studies, perform equipment maintenance activities, and maintain accurate laboratory documentation while ensuring compliance with ISO 13485 quality system requirements.

Microbiological Testing Perform routine microbiological testing including: Product bioburden testing Sterility testing Bacterial endotoxin testing Microbial water testing Compressed air microbiological testing Environmental monitoring sample processing Microbial limits testing, as applicable Environmental Monitoring Support the laboratory environmental monitoring program by performing: Viable air sampling Surface monitoring Personnel monitoring Non-viable particulate monitoring Cleanroom monitoring activities Environmental sample incubation and analysis Trending data collection and reporting support Microbial Identification & Characterization Perform microbiological identification activities including: MALDI-TOF microbial identification Gram staining Colony morphology characterization Pure culture isolation Culture maintenance and preservation Investigation support for environmental and product isolates Laboratory Support Activities Prepare microbiological media and reagents. Perform growth promotion testing and media qualification activities. Maintain laboratory inventory and culture stocks. Prepare testing supplies and sample kits. Receive, log, and process incoming samples. Maintain laboratory housekeeping and organization. Analytical Testing Perform routine analytical testing activities including: Total Organic Carbon (TOC) testing of water systems TOC testing associated with reusable medical device cleaning validations Endotoxin testing of water and product samples Data review and documentation of analytical results Validation Support Responsibilities Assist with execution of: Reusable device cleaning validation studies Disinfection validation studies Steam sterilization validation studies Environmental monitoring qualification activities Equipment qualification protocols Method verification and validation activities Responsibilities may include: Sample preparation Test execution Data collection Equipment setup Protocol and report support Documentation review Equipment