POSITION OBJECTIVE: Performs various microbiological sampling and testing in an FDA regulated environment.
The following shifts are currently open:
- 1st shift (7 AM to 3:30 PM, Monday through Friday)
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)
- 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.
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.