Supervisor, Sterilization & Microbiology Lab

Job Title 
Supervisor, Sterilization and Microbiology Lab

FLSA Status 
Exempt

Work Arrangement
Onsite

Position Summary 

The Laboratory Supervisor will supervise / coordinate / manage biological and chemical testing related to routine product release, in-process quality testing, terminal sterilization, environmental quality, and biological safety (biocompatibility) of new products/materials for all ICU Medical products:  
Essential Duties & Responsibilities
   The position has a strong emphasis on project management, specifically ethylene oxide sterilization cycle development, qualification, and cycle optimization with respect to parametric release, aeration, residuals, and minimization of degas times 
   Coordinate sampling and testing of products for presence of pyrogen, heparin activity testing, and bioburden levels; and, the manufacture of heparin benzalkonium complex and solution, Cyclohexylamine (CHA) and other chemicals for use in catheter and other medical devices manufacturing.
   Coordinate testing of incoming components using FT-IR, melt flow, density, specific gravity, pH, and corrosion resistance
   Coordinate sampling and testing of in-house purified water, and those portions of the manufacturing process which utilize water, for presence of endotoxin and/or, microbial load, pH, TOC, and conductivity
   Coordinate testing of biological indicators used in the monitoring and release of ethylene oxide sterilization cycles
   Supervise Biological Quality Laboratory for the Salt Lake City facility.
   Review and approve technician test results for conformance to the applicable test method; and, investigate and disposition out-of-specification test results, including the generation of relevant exception documents
   Manage and coordinate the quality aspects of the gamma, e-beam, and ethylene oxide terminal sterilization processes for ICU Medical products ensuring compliance to requirements on ISO standards for EO and Radiation sterilization.
   Evaluate all new products, modified products, or material changes, to assess sterilization and biocompatibility impact per the requirements of ISO 10993.  Coordinate micro-challenge and biocompatibility testing when necessary
   Performs other functions as necessary or as assigned

Knowledge & Skills
   Familiarity with cGMP, cGLP, FDA, and compendial guidelines governing the manufacture and release of sterile, single-use medical devices
   Good organizational and communication skills required
   Knowledge of Microsoft Word, Excel, and Outlook

Minimum Qualifications, Education & Experience
   Must be at least 18 years of age
   Bachelor's degree or equivalent experience in biological or chemical science required
   Ability to supervise and manage projects and subordinates to accomplish departmental goals in a timely manner

Work Environment
   This is largely a sedentary role. 
   May perform job functions within the laboratory
   This job operates in a professional office environment and routinely uses standard office equipment.
   While performing the duties of this job, the employee may be required to sit or stand for long periods of time; depending on the machine they are operating
   Must be able to occasionally move and lift objects of up to 25 lbs
   Typically requires travel less than 25% of the time

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.