Microbiology Quality & Sterility Assurance Scientist

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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.

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.

Essential 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

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 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

Environmental monitoring equipment

Support:

Equipment calibration activities

Preventive maintenance activities

Qualification and requalification testing

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.

Required Qualifications

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.

Required 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

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

Knowledge & Skills

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

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.

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 & 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,  external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills: