"Cyclotron Facility Engineer"

A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

The Cyclotron Facility Engineer will be responsible for overseeing operation, maintenance, troubleshooting and repair of the Department of Radiology's Cyclotron and Radiochemistry Facility equipment, including two GE PETtrace cyclotrons, GE FASTLab and TRACERLab synthesis modules, state-of-the-art analytical equipment, as well as liaising with UM facilities personnel to ensure facility infrastructure such as HVAC, electrical systems, compressed gases, P-tubes and chilled water is maintained for facility needs. The role will also support isotope production (including 18F, 11C, 68Ga) using liquid targets, and play an essential role in ensuring smooth running of site operations (manufacturing, quality control and distribution of PET radiopharmaceuticals to University Hospital and satellite sites throughout the state of Michigan) by ensuring equipment is maintained in a validated compliant state. In addition to this primary responsibility, the position will train staff on facility equipment, liaise with vendors for routine maintenance and other contract services, and support site leadership in meeting facility goals, maintaining a safety culture, and regulatory compliance.

• Assure the GE PETtrace cyclotrons, GE FASTLab and TRACERLab synthesis modules, Comecer hot-cells and cyclotron vault door, air quality and QC analytical equipment is in good operating order and available for radiopharmaceutical production according to the facility production schedule;
• Assist QA and facility leadership in operating a cyclotron facility that meets all applicable regulatory requirements, including Nuclear Regulatory, State of Michigan, Food and Drug Administration, and other applicable federal, state, and local regulations. This includes assuring all equipment is maintained in a validated compliant state (e.g. completion of IQ/OQ/PQ, annual preventive maintenance etc);
• Work with facility UM RSO, radiation safety services and facility leadership to maintain a culture of safety, including safe operation of the accelerator (e.g. conducting interlock checks and other tests as required by facility and UM NRC licenses and State of Michigan);
• Oversee operation of two GE PETtrace cyclotrons and a fleet of radiochemistry modules, including operating the accelerators, day-to-day troubleshooting and training/qualifying facility staff to use the cyclotrons and synthesis modules;
• Act as the on-site primary engineer under vendor in house maintenance contract(s) for troubleshooting and maintenance of the cyclotrons, radiochemistry modules, hot-cells / vault door, analytical instrumentation and liaise with UM facilities as point person for other facility equipment (e.g, compressed gases, HVAC, electrical, chilled water);
• Provide electronics and software support to facility as needed to modify, build, or reprogram cyclotron and synthesis operations;
• Perform all routine maintenance, calibration, and repair tasks for the cyclotrons, process cabinets, supporting high voltage, magnet and mechanical systems, the liquid target systems, and associated software;
• Assist with routine maintenance, calibration, and repair tasks for the radiochemistry synthesis modules, associated systems such as HPLC systems, and software;
• Perform routine maintenance on other facility equipment (hot-cells, analytical instruments, support infrastructure, other equipment) as needed;
• Maintain an in-house inventory of spare parts and vendor supplied components to maximize the uptime of all facility equipment;
• Assist radiochemistry production and QC scientists in promptly troubleshooting cyclotron, synthesis module and/or other equipment problems as they arise;
• Work with the quality assurance unit and facility leadership to maintain accurate complete records of all the machine's operation, calibration, and maintenance, electronically and/or in physical log books; 
• Invent, modify, or improve cyclotron/synthesis module components and targetry, through collaboration with GE as needed, to support the growing mission of the facility;
• Maintain training and qualification in all aspects of radiopharmaceutical operations noted above;
• Assist as needed with other duties for the site, including: 
• materials acceptance and quarantine;
• cleaning of the facility to maintain air quality standards and compliance according to established procedures;
• Radiopharmaceutical quality control, including sterility and environmental monitoring; 
• equipment maintenance/qualification/calibration/system suitability;
• investigation (NCR/OOS) and corrective and preventative actions (CAPA);
• SOP (Standard Operating Procedure) writing, maintenance and review as they pertain to equipment and maintenance;
• inspection readiness;
• Assist RSO, radiation safety services and facility leadership in running radiation safety program, including assisting with radiation wipes and surveys, dosimetry etc;
• Assist facility leadership in acquisition, installation and operationalizing new capital equipment as needed for future facility modifications, including accelerator equipment, clean room modifications, hot-cells, automated synthesis or packaging equipment, and analytical equipment.
• Perform other job-related duties as assigned.

Requires a bachelor's degree in EE, physics, nuclear engineering or related field, or equivalent experience;

• Superior teamwork, multi-tasking, and time/project management skills are essential;
• Excellent communication, analytical, problem solving, and computer/pc skills (including proficiency in Microsoft Suit and related software);
• Ability to work varying shifts;
•  Ability to build and maintain excellent working relationships with facility staff, UM facilities workers, and providers of routine maintenance and other contract services and material suppliers is  expected.

Experience working in an industrial or academic PET facility is highly desirable;

• Experience with a GE PETtrace (or related) cyclotron and radiochemistry synthesis modules is highly desirable (additional GE cyclotron training can be provided);
• Familiarity with a GMP manufacturing environment and working with NRC, State and FDA regulations is highly desirable;
• Knowledge of radiopharmaceutical production and distribution desired;
• Experience working in a multidisciplinary radiopharmacy team environment is strongly preferred

40 h per week, day shift. Some out of hours OT required depending on cyclotron maintenance requirements.

This position is covered under the collective bargaining agreement between the U-M and the U-M Skilled Trades Union, Inc., which contains and settles all matters with respect to wages, benefits, hours and other terms and conditions of employment.