Job Description Summary

　　The Microbiologist is responsible for in-process and release testing of injectable pharmaceutical finished products. The role includes final product microbiological testing, maintenance of controlled areas, environmental monitoring, analysis of results, raw material testing, growth promotion testing and performing microbiological identification. The Microbiologist I participates in the periodic review of procedures and supports validation studies as they pertain to microbiology.

　　Our Pharmaceutical Diagnostics (PDx) business is a global leader in imaging agents, used to improve and enhance the images that radiologists use to diagnose and monitor disease. We support healthcare professionals in the administration of neurology, cardiology and oncology procedures that are used to image three patients around the world, every second.

　　Job Description

　　Key responsibilities/essential functions include:

　　Perform required bioburden, sterility and bacterial endotoxin testing on final products and raw materials utilizing specialized equipment

　　Perform viable and non-viable environmental monitoring

　　Operate non-viable particle counter/facility monitoring systems

　　Monitor sterility and environmental media for microbiological growth and perform incoming growth promotion testing

　　Participate in validation projects requiring microbiology support

　　Perform required procedures to initiate isolate identification from environmental samples and sterility tests

　　Perform computer data entry with programs such as Microsoft Excel and MODA

　　Maintain accurate records of environmental data and finished product/raw material testing

　　Perform sample collection and testing of the Reverse Osmosis system that feeds the production autoclaves; operate a Total Organic Carbon analyzer

　　Prepare supplies for sterilization (autoclave) and depyrogenation (dry heat oven)

　　Perform requalification testing for gown and aseptic qualified operators

　　Evaluate documentation and GMPs as they relate to microbiological issues

　　Contribute to process improvement through Lean, 5S and six sigma tools

　　Understand maintenance and use of biological indicators

　　Create/perform unscheduled work orders and preventative maintenance records for laboratory upkeep

　　Quality Specific Goals:

　　Knowledge and understanding of acceptance activity requirements for incoming, in-process, and final inspection requirements (as associated with job type/position) to ensure that product conforms to its specification and out of specification items are properly handled

　　Knowledge and understanding of Shop Orders, Concessions, Calibration, Preventative Maintenance, Material Identification & Segregation, documentation configuration control practices; documentation & disposition of non-conforming material, Part 11 compliance and Good Documentation Practices requirements, as associated with this job type/position

　　Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position

　　Complete all planned Quality & Compliance training within the defined deadlines

　　Identify and report any quality or compliance concerns and take immediate corrective action as required

　　Required Qualifications:

　　Bachelor’s degree in Microbiology or related Science degree

　　Ability to speak, understand, read and write in local language

　　Proficiency with Microsoft Office Suite (including Access)

　　Availability for early shifts and weekends as needed

　　Ability to distinguish color

　　Knowledge of microbiological techniques (gram stain/microbial ID, aseptic, gowning, etc.)

　　Ability to lift 25lbs

　　Preferred Qualifications:

　　Cleanroom experience

　　Experience with electronic data tracking systems such as MODA

　　Experience with bioburden, sterility and bacterial endotoxin testing

　　We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership –always with unyielding integrity.

　　Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

　　#LI-MA4

　　Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.

　　Additional Job Description

　　Additional Information

　　Compensation Grade

　　OTHSAL

　　GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunities Employer. (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf) Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

　　GE HealthCare will only employ those who are legally authorized to work in the United States for this opening.

　　While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

　　Relocation Assistance Provided: No