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Engineer I - Gilroy, United States - SOFIE
Description
Title | Cyclotron-Support Engineer IDepartment | Technical Services
Reports To | Field Service Engineer
Overview
The Cyclotron-Support Engineer I is accountable for the safe and routine operation, maintenance, and repair of one or more particle accelerators in SOFIE's PET radiopharmacy, which manufactures PET diagnostics under 21 CFR 212 guidelines.
Additionally, the Cyclotron-Support Engineer I is responsible for first-line troubleshooting, maintenance, and repair of equipment associated with manufacturing, including manipulator's arms, lead shielded hot cells, radiosynthesizers, etc.
The individual should be capable of independent decision-making abilities for most cyclotron and facility situations and will be called upon to troubleshoot non-routine manufacturing concerns.
Essential Duties and Responsibilities§ Operate the cyclotron(s) according to proper operating procedures when the manufacturing schedule requires (will include night shifts; may include weekend shifts).
§ Perform routine, non-routine, scheduled, and emergency maintenance on the cyclotron(s).
§ Complete documentation related to cyclotron operations per work instructions, including preventative maintenance, repair, and audit logs.
§ Plan and execute accelerator maintenance activities on a schedule determined by the Tech Services management team.
§ Perform diagnosis and repair on the following: Electronic equipment, electro-pneumatic systems, high vacuum systems, deionized chilled water systems, high voltage, target, and high-power RF systems.
§ Provide timely information to supervisors regarding equipment operation and status.
§ As first-line support, maintain, and repair all PET manufacturing equipment at the facility, including lead-shielded hot cells, manipulator arms, radiosynthesizers, etc.
§ With the Facility Manager, oversee the work of all third-party contractors on equipment related to manufacturing.
§ Perform radiation safety duties to SOFIE Radiation Compliance/Environmental Health and Safety Program standards to ensure compliance with all regulations under the Corporate and site RSO.
§ Ensure compliance with all procedures and regulations within the site under the Quality Assurance program as applicable, including participating in exception document reporting (e.g. deviations, corrective and preventative action plans, out-of-specifications, etc.)
§ Provide technical training and support to other employees,
§ Provide after-hours on-call support to the site as needed.
§ Submit all work tickets, time cards, and expense reports in a timely manner.
§ All other duties as required.
Qualifications
§ 2+ years of cyclotron experience or an Associate Degree in a Technical Discipline required.
§ Working knowledge of digital and analog circuitry required.
§ Able to troubleshoot electronics down to the component level preferred.
§ Ability to understand the detailed theory of operation for most accelerator systems preferred.
§ Ability to read and interpret mechanical and electrical drawings required.
§ Knowledge of radiation survey meters required.
§ Experience in diagnosis and repair of equipment failures required.
§ Experience with high voltage training preferred.
§ Knowledge of basic cGMP practices and procedures preferred.
§ Ability to define problems, collect data, establish facts, and draw valid conclusions required.
§ Experience working with radioactive materials required.
§ Ability to climb ladders and stairs, work in protective clothing, operate in confined spaces (i.e. inside or underneath the cyclotron) and lift a minimum of 50 lbs. required.
§ Occupational exposure to ionizing radiation required.
§ Excellent communication skills, ability to be detail-oriented, and dependability required.
§ Experienced in Microsoft Suite required.
§ Travel:
up to 20%
