Position Summary


The Microbiology Technician is responsible for product testing, set-up, trouble shooting, and development of department procedures. Perform and document microbiological testing for release of incoming components and finished product to support quality assurance/quality control and manufacturing operations. This role will also monitor particulate and other biological substance levels in controlled clean room areas and participate in validation activities. For all testing that is done it is expected that troubleshooting will be completed for a source of error as well as interpret the significance of results, including trend analysis. In this position you will have responsibilities for final release of product as sterile; review sign-off release certificates and assist with training other lab employees as requested by supervisor.


Essential Duties & Responsibilities


• Develop department procedures for use of GC equipment.

• Set up and troubleshoot software and equipment; make routine repairs and adjustments.

• Coordinate retrieval of samples that should be tested.

• Perform ETO testing on product samples.

• Perform dissipation studies.

• Complete instrument validation.

• Interpret significance of results; perform trend analysis.

• Performs general laboratory and test supply maintenance.

• Performs other functions as necessary or as assigned.

• prepare product for resting per written procedures.

• Record results on computer and specified forms.

• Perform troubleshooting on the system if problems occur.

• Interpret significance of the results. Including trend analysis.

• Review and approve test data against action limits.

• Perform environmental bioburden testing per written procedure.

• Investigate all test results.

• Perform air sampling following written procedure.

• Identify needs to new procedures.

• Conduct sterility testing of sample products.

• Assist with development, modification, and validation of new or existing department procedures.

• Other duties as assigned.



Minimum Qualifications, Education & Experience


• Computer proficiency and adaptability working with a variety of databases, word processing, spreadsheet, etc.

• Ability to work in a team environment with shifting priorities and requirements.

• Previous experience testing medical devices preferred.

• Good organizational and communication skills required.

• Associate degree or certificate as a Medical Technician including course work in Microbiology and Chemistry with a minimum of 5 years' experience performing microbiological tests and sterilization monitoring in a medical device of pharmaceutical company preferred.

• Technical knowledge in the field required.

• Knowledge of physical sciences, laboratory equipment.

• Strong written and verbal communication skills required.

• 0-1 years related experience.

• Must be at least 18 years of age.



Work Environment


• While performing the duties of this job, the employee is regularly required to talk or hear.

• This job operates in a professional office environment as well as a laboratory setting. This role routinely uses standard office equipment such as computers, phones, and photocopiers.

• Work may be performed in a clean room environment.

• While performing the duties of this job, the employee may be required to sit or stand for long periods of time.

• Must be able to occasionally move and lift objects of up to 25 pounds.


ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.