Senior Microbiologist

Sr. Microbiologist-STERILIZATION

(Through end of October 2024 // REMOTE, team based in Memphis, TN):

HM's Top 3:

1. Practical experience with sterilization, microbiology, and controlled environments.
2. Standards and guidelines applicable for this role include, but are not limited to, ANSI/AAMI/ISO 17665-1, ISO 17664-1 and -2, AAMI TIR12, AAMI TIR30, ISO 11135, ISO 11737-3, ANSI/AAMI ST72, ISO 11737-1, ISO 14644 (series), EN 17141.
3. Exposure to various sterilization modalities and testing methods, including Endotoxin testing and Moist Heat (Steam), Gamma Irradiation, and EtO sterilization.
4. Ability to think critically to develop complex plans and execute actions according to plan.

Education Required/Years’ Experience Required: Bachelors in Scientific discipline with 2-7 years of experience

Description:

Work with single use devices and will need to have hands-on experience with product bacterial endotoxin programs, Gamma Irradiation, and Ethylene oxide sterilization. Work with re-usable devices and will need hands-on experience with moist heat sterilization. Practical experience with sterilization, microbiology and controlled environments.

Duties:

• Analyzes chemical, biological or microbiological products, raw materials, in process materials, release test samples or stability samples in support of the company's quality program.
• Interprets and evaluates the analyses in terms of accuracy and precision compared against established specifications and recommends and implements corrective action where necessary.
• Develops, validates, and implements controlled environment methods.
• Applies existing techniques and procedures with recommendations and implementation of modification for improved efficiency, or devises and develops new analytical methods and techniques.
• Performs qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation.
• May also be involved in establishing requirements for the transfer of methodology from R&D.