MASTER JOB TITLE: Microbiology Technician

POSITION TITLE: Microbiology Technician


POSITION OBJECTIVE: Performs various microbiological sampling and testing in an FDA regulated environment.

REPORTS TO: Quality Control Microbiology Manager



Essential Job Functions/Responsibilities

  • Perform environmental monitoring of ISO5/ISO7/ISO8 manufacturing areas (viable air, viable surface, and non-viable particulate) as well as inspection for compliance.
  • Complete accurate and legible written data entry on records and documents for tests performed.
  • Accurate computer data entry, trending, and presentation.
  • Support Media Fill Validations, Engineering Validations and Cleaning Validations.
  • Collection and testing (Bioburden/TOC/Conductivity) of water samples throughout the facility.
  • Raw Material/Prefiltration Bioburden sample testing.
  • Media check in and growth promotion.
  • Equipment preparation and sterilization.
  • Preparation of microbial ID samples.
  • Off testing of incubated microbial media and plates.
  • Use standard laboratory equipment including pH meter, balance, incubator, autoclave, pipettes, and water bath.
  • Stocking/ordering lab supplies.
  • Assess and revise microbiology/laboratory procedures as needed.
  • Support in Sterility/Endotoxin/MET testing as needed.
  • Support microbiology laboratory investigations including EE/Issue reviews/OOS/OOT/No Tests/DIR/CAPA.
  • Promote and maintain safe and healthy working conditions in his/her assigned work area; instructs and enforces compliance with established safe work practices and procedures; ensures assigned trainees receive appropriate training and information necessary to conduct their activities in a safe and healthy manner.
  • May perform other duties as assigned.

Required Education & Experience

  • Bachelor’s in Microbiology/Biology or closely related field


  • Associates Degree in Microbiology/Biology or closely related field with a minimum of 2 years relevant experience (working in a microbiology laboratory with experience in an FDA regulated biopharmaceutical /medical device industry)


  • May consider candidates with a High School diploma (or equivalent) with a minimum of 4 years relevant experience.

Required Skills & Abilities:

  • Upon hire, must successfully complete training on aseptic gowning procedures and demonstrate the ability to aseptically gown. (required)
  • Experience in microbiological principles and applications related to microbial ID, validation or clean room technology. (preferred)
  • Accurate/legible completion of records and documents for tests performed, and accurate computer data entry.
  • Training in cGMP/cGLP for laboratory operations and compliance to regulatory guidelines with working knowledge of environmental monitoring, endotoxin testing, USP sterility or bioburden test methods. (preferred)
  • Proficient in the use of standard laboratory equipment including pH meter, balance, incubator, autoclave, pipettes or water bath. (preferred)
  • Training to ISO, USP or GMPs standards. (preferred)
  • Technology Skills (Windows, Word, Excel, Power Point). (preferred)

Working Conditions:

  • Ability to wear high level aseptic gowning with face mask for long periods of time (required).
  • Ability to stand for long periods of time (required).
  • Must have a valid driver’s license for travel to other Athenex locations as needed.

Apply for position now

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Are you trained in cGMP for laboratory operations?
Check off all of the standard laboratory equipment you have experience using:
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