POSITION OBJECTIVE: Performs various microbiological sampling and testing in an FDA regulated environment.
Essential Job Functions/Responsibilities
- Perform Sterility, Endotoxin, MET testing.
- Perform and review environmental monitoring of ISO5/ISO7/ISO8 manufacturing areas (viable air, viable surface, and non-viable particulate) as well as inspection for compliance.
- Perform and support Media Fill Validations, Engineering Validations and Cleaning Validations.
- Accurate/legible completion of records and documents for tests performed, and accurate computer data entry/trending/presentation.
- Collection and testing (Bioburden/TOC/Conductivity) of water samples from throughout the facility.
- Raw Material/Prefiltration Bioburden sample testing.
- Media check in and growth promotion.
- Equipment preparation and autoclaving.
- 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.
- Revision of microbiology/laboratory procedures.
- Support microbiology laboratory investigations including EE/Issue reviews/OOS/OOT/No Tests/DIR/CAPA.
- Responsible for promoting and maintaining 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 Degree in Microbiology/Biology or closely related field with a minimum of 1 year of experience working in a microbiology laboratory in an FDA regulated biopharmaceutical /medical device industry
- Master’s Degree in Microbiology/Biology or closely related field.
- Associates Degree in Microbiology/Biology or closely related field with a minimum of 3 years of experience working in a microbiology laboratory in an FDA regulated biopharmaceutical /medical device industry
May consider candidates with a High School diploma (or equivalent) with a minimum of 5 years of experience working in a microbiology laboratory in an FDA regulated biopharmaceutical /medical device industry
Required Skills & Abilities:
- Must successfully complete training on aseptic gowning procedures and demonstrate the ability to aseptically gown upon completion. (required)
- Experience in microbiological principles and applications related to microbial ID, validation, or clean room technology. (preferred)
- Training in cGMP/cGLP for laboratory operations and compliance to regulatory guidelines with working knowledge of environmental monitoring, endotoxin testing, sterility testing, and/or Microbial Enumeration testing 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).
- This position requires the passing of a pre-employment drug screen in compliance with federal drug testing rules.
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.
This is a safety sensitive position and/or a position which has the potential to significantly impact the health or safety of other employees or members of the public. It requires passing a pre-employment drug screen in compliance with federal drug testing rules.