Cyclotron Facility Engineer (Kailua)

Join a pioneering company dedicated to revolutionizing cancer detection and treatment in Hawaii. Our brand-new facility is equipped with cutting-edge technology, allowing us to make a meaningful impact in cancer diagnosis and patient care. As a small, dynamic team, we foster a collaborative, family-like environment where innovation thrives. Here, youll have the unique opportunity to influence strategy and help introduce groundbreaking new treatments to the state. If youre passionate about advancing cancer care and want to be part of a team shaping the future of healthcare, wed love to have you on board!

Role Summary :

The Cyclotron Facility Engineer will be responsible for overseeing operation, maintenance, troubleshooting and repair of HIT facility equipment, including a newly installed GE PETtrace cyclotron, FASTLab synthesis modules, state-of-the-art analytical equipment and other infrastructure such as a clean room, HVAC and electrical systems, compressed gases and chilled water. The role will also support isotope production (including

18

F,

68

Ga) using both liquid and solid targets, and play an essential role in ensuring smooth running of site operations (manufacturing, quality control and distribution of PET and SPECT radiopharmaceuticals to satellite sites throughout the state of Hawaii) 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 company goals, building a safety culture and regulatory compliance.

Job Responsibilities and Duties :

Assure the GE PETtrace cyclotron, GE FASTLab synthesis modules, Comecer hot-cells, clean room and QC analytical equipment is in good operating order and available for radiopharmaceutical production according to the HIT pharmacy schedule;

Assist QA and facility leadership in operating a cyclotron facility that meets all applicable regulatory requirements, including Nuclear Regulatory, State of Hawaii, Food and Drug Administration, and other applicable federal, state, and local island 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 RSO and leadership to maintain a culture of safety in the facility, including safe operation of the accelerator (e.g. conducting interlock checks and other tests as required by HITs NRC license);

Oversee operation of the GE PETtrace cyclotron and FASTLab radiochemistry modules, including operating the accelerator, day-to-day troubleshooting and training / qualifying facility staff to use the cyclotron and synthesis modules;

Act as the on-site primary engineer under vendor in house maintenance contract(s) [SP1] for troubleshooting and maintenance of the cyclotron, radiochemistry modules, hot-cells, analytical instrumentation and other facility equipment (e.g. clean room, 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 cyclotron, the supporting high voltage, magnet and mechanical systems, the liquid and solid target systems, and associated software;

Perform all routine maintenance, calibration, and repair tasks for the GE FASTLab 2 radiochemistry synthesis modules, associated systems such as HPLC+, and software;

Perform routine maintenance on other facility equipment (hot-cells, analytical instruments, support infrastructure, clean room, other equipment) as needed;

Maintain an in-house inventory of spare parts and vendor supplied components to maximize the uptime of all HIT facility equipment;

Assist radiochemistry production and QC scientists in promptly troubleshooting cyclotron, 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 machines 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 HIT;

Trained and qualified in all aspects of radiopharmaceutical operations noted above, and able to assist with production, quality control testing and distribution when required;

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; [SP2]
• 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 in running radiation safety program, including assisting with radiation wipes and surveys on shipping containers, supplies, incoming packages, and workspaces are completed;

Assist facility leadership in acquisition, installation and operationalizing new capital equipment as needed forfuture 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.

Job Requirements Skills Education :

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

Additional 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 required;

Familiarity with a GMP manufacturing environment and working with board of pharmacy, NRC and FDA cGMP regulations is highly desirable;

Knowledge of radiopharmaceutical production and distribution desired;

Experience working in a multidisciplinary radiopharmacy team environment is strongly preferred;

Experience with cyclotrons, radionuclide generators, radiochemistry synthesis, US FDA cGMP, QC testing (e.g. HPLC, GC, TLC, sterility testing), radiation safety principles, isotope production and analytical equipment troubleshooting and maintenance a plus;

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 providers of routine maintenance and other contract services and material suppliers is expected.

Salary : $90,000-$140,000

Physical and Intellectual Requirements :

Required are a mechanical aptitude; manual dexterity for manipulating small items; ability to lift between 16 to 50 lbs. and to handle frequent crawling, stooping, crouching, and kneeling; ability to analyze situations, set priorities and meet deadlines while maintaining attention to detail in a fast-paced and dynamic environment; effective organizational skills; a commitment to continuous learning; an ability to work well both independently and as part of a team.

Come join our team and begin a fulfilling career with us by applying today.

Hawaii Isotope Technology is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.

Benefits Include :

401(k) retirement benefit program

Medical

Dental care

Life insurance

Paid time off

Vision care