Microbiology Quality & Sterility Assurance Scientist

About the Role

Depuy Synthes, a member of the Johnson & Johnson Family of Companies, is seeking a Microbiology Quality & Sterility Assurance Scientist to support medical device development, manufacturing, contamination control, and validation programs in a regulated laboratory environment. This position operates under ISO 13485 quality system requirements and performs testing in accordance with approved procedures, protocols, work instructions, and applicable regulatory requirements.

Responsibilities

• 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, and microbial limits testing.
• 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, and trending data collection and reporting.
• Microbial Identification & Characterization
  • Perform microbiological identification activities including MALDI-TOF microbial identification, Gram staining, colony morphology characterization, pure culture isolation, culture maintenance and preservation, and 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, and endotoxin testing of water and product samples.
  • Review and document analytical results.
• Validation Support
  • Assist with execution of reusable device cleaning validation studies, disinfection validation studies, steam sterilization validation studies, environmental monitoring qualification activities, equipment qualification protocols, and method verification and validation activities.
• Equipment Responsibilities
  • 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, and environmental monitoring equipment.
  • Support equipment calibration, preventive maintenance, qualification and requalification testing, and troubleshooting of routine laboratory equipment issues.
• Documentation & Quality Responsibilities
  • 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.

Requirements

• Education
  • 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
  • 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.
• Preferred Experience
  • 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
• Knowledge & Skills
  • 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
• Physical Requirements
  • 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.