Microbiology Quality & Sterility Assurance Scientist

Johnson & Johnson Innovative Medicine•Warsaw, IN

1d•Onsite

About The Position

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. Position 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.

Requirements

Associate degree in Microbiology, Biology, Biotechnology, Chemistry, Biomedical Science, or related scientific discipline with 2+ years of laboratory experience; OR Bachelor's degree in Microbiology, Biology, Chemistry, Biochemistry, Biomedical Sciences, or related scientific discipline.
Experience working in a microbiology, chemistry, pharmaceutical, medical device, healthcare, academic, contract testing, or regulated laboratory environment.
Understanding of aseptic laboratory techniques.
Experience with microbiological culture techniques.
Experience performing laboratory documentation and recordkeeping.
Familiarity with basic laboratory instrumentation and troubleshooting.
Ability to stand for extended periods.
Ability to lift laboratory supplies up to 30 pounds.
Ability to work in laboratory and controlled environment settings.
Ability to wear required personal protective equipment (PPE).
Ability to perform repetitive pipetting, sample handling, and data entry activities.

Nice To Haves

Experience with one or more of the following: Environmental monitoring, Bioburden testing, Sterility testing, Endotoxin testing, Water system monitoring, Microbial identification, MALDI-TOF systems, Gram staining, TOC analysis, Media preparation, Cleanroom operations, Medical device testing, Cleaning validation studies, Laboratory quality systems, ISO 13485 environments, LIMS software systems
Preferred knowledge of: Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), ISO 13485, ISO 14644 cleanroom concepts, Basic microbiology principles, Contamination control practices, Laboratory safety procedures
Demonstrated ability to: Follow detailed procedures accurately, Perform precise and repetitive laboratory testing, Maintain excellent organizational skills, Work independently and as part of a team, Prioritize multiple assignments, Communicate technical information effectively

Responsibilities

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
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
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
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.
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
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
Operate and maintain laboratory equipment including: MALDI-TOF systems, Particle counters, Air samplers, Endotoxin testing instruments, TOC analyzers, Incubators, Autoclaves, Biosafety cabinets, Refrigerators and freezers, Laboratory water systems, Environmental monitoring equipment
Support: Equipment calibration activities, Preventive maintenance activities, Qualification and requalification testing, Troubleshooting of routine laboratory equipment issues
Complete laboratory documentation accurately and contemporaneously.
Maintain test records, logbooks, worksheets, and electronic data.
Follow approved SOPs, protocols, and work instructions.
Support investigations for deviations, out-of-specification results, and environmental monitoring excursions.
Participate in CAPA and continuous improvement initiatives.
Support internal, customer, and regulatory audits.
Maintain compliance with ISO 13485 quality system requirements and laboratory data integrity expectations.