GENERAL SUMMARY/ OVERVIEW STATEMENT

To support the two-fold mission of the Nuclear Medicine's Biomedical Imaging Core (BICOR):

• Providing continuous supply of PET radioisotopes in support of Massachusetts General Brigham Healthcare clinical operations.
• Providing on demand supply of radioisotopes in support of research programs at Brigham and Women's Hospital (BWH), Dana Farber Cancer Institute, Children's Hospital, and Harvard Medical School

PRINCIPAL DUTIES AND RESPONSIBILITIES:

The incumbent will perform all the following as a member of an interdisciplinary team, inclusive of a cyclotron engineer, radiochemists, GMP production staff, and nuclear pharmacists.

Supporting the Lead Cyclotron Engineer, the incumbent will operate, maintain, and improve the BICOR accelerator and associated equipment. Specifically:

• Assure the cyclotron is in good operating order and available for production according to the pharmacy schedule
• Operate the cyclotron, oversee the operation of the cyclotron, train, and qualify cyclotron operators.
• Perform routine maintenance, calibration, and repair tasks for the cyclotron, the supporting electromechanical systems, target systems, and the software.
• Maintain a balance of in-house spare parts and vendor supplied components to maximize the uptime available of all equipment.
• Maintain accurate complete records of all the machine's operation, calibration, and maintenance, both electronically and in the appropriate logbooks.
• Maintain metrics for the production organization.
• Assist radiochemistry technicians, faculty and staff in promptly troubleshooting cyclotron operation and targetry problems as they arise.
• Work with field service personnel as necessary under the cyclotron maintenance contract.

Supporting radiopharmaceutical manufacturing operations, the incumbent will routinely participate in the preparation of components and equipment utilized in radiochemical synthesis. Specifically:

• Perform all routine maintenance, calibration, and repair tasks for the synthesis modules in relation to the target systems. Assure the automated synthesis modules and quality control instrumentation are in good operating order and available for production.
• Perform routine manufacturing processes in support of PET GMP production runs. Contribute to and maintain an appropriate inventory of material needed to support PET GMP operations.
• Work with field service personnel as necessary under the synthesis module maintenance contracts.
• Assure equipment is maintained in a validated, compliant state in accordance with standard operating procedures.
• Train and qualify technicians to work with synthesis modules.
• Contribute to and maintain a quality metrics database.
• Assist in the development, implementation, and training of standard operating procedures.

The incumbent will provide general engineering support to the BICOR facility. Specifically:

• Maintain hot cells, manipulators, custom build hardware to assure all work areas are maintained in good working order and remain in a state of validation.
• Use past experience to invent, design, construct, and implement custom hardware in support of the manufacturing and radiopharmacy operations.
• Work with BWH engineering and maintenance staff to assure proper monitoring, adjustment, and repair of utilities for the BICOR facility to maintain a state of compliance.

The incumbent will assure that all BICOR staff comply with State and institutional radiation safety practices by:

• Participating in the investigation and resolution of all anomalous occurrences.
• Contributing to and maintaining the facility's radiation safety database.

Build and maintain excellent working relationships with providers of routine maintenance and other contract services and material suppliers.

QUALIFICATIONS

• BS in a related engineering field (Electrical Engineering, Physics) with 2 years of experience operating a PET production cyclotron, or equivalent experience.
• Hands on experience with electronics and electromechanical systems including troubleshooting, repair, and calibration is required.
• Experience with operation and maintenance of power systems, vacuum systems, and both analog and digital electromechanical control systems is preferred.
• Must be able to work on trained tasks independent from direct oversight.
• Must be able function as a member of a multidisciplinary team.

SKILLS/ ABILITIES/ COMPETENCIES

• Experience within pharmaceutical GMP compliant operations is preferred.
• Experience with a GE PETTrace (or similar) cyclotron is preferred.
• Experience using computer aided design and fabrication is preferred.