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Senior Engineering Tech - Somerset, United States - SOFIE
Description
Engineering TechnicianTitle | Cyclotron-Engineering Technician
Department | Technical Services
Reports To | Field Service Engineer
Overview
The Cyclotron-Engineering Technician is accountable for the safe and routine operation, maintenance, and repair of equipment in SOFIE's PET radio pharmacy, which manufactures PET diagnostics under 21 CFR 212 guidelines.
The primary responsibility of this role is first-line troubleshooting, maintenance, and repair of electro/mechanical equipment associated with manufacturing, including manipulator arms, lead shielded hot cells, radiosynthesizers and cyclotrons and associated subsystems.
The individual should be capable of independent decision-making abilities for most site and facility situations and will be called upon to trouble shoot non-routine manufacturing concerns.
Essential Duties and Responsibilities§ Perform routine, non-routine, scheduled, and emergency maintenance on the cyclotron(s).
§ Complete documentation related to maintenance activities per work instructions, including preventative maintenance, repair, and audit logs.
§ Plan and execute 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.
§ Provide timely information to supervisors regarding equipment operation and status.
§ As a 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,
§ Operate the cyclotron(s) according to proper operating procedures when manufacturing schedule requires (will include night shifts; may include weekend shifts).
§ 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
§ Associates degree in engineering technology or 2+ years experience working as electro-mechanical technician.
§ Military training/experience a plus.
§ Working knowledge of digital and analog circuitry a plus.
§ Able to troubleshoot electronics down to the component level preferred.
§ Ability to read and interpret mechanical and electrical drawings required.
§ Expert use of hand tools required.
§ Previous experience working in hazardous environments required.
§ Knowledge of lockout/tagout processes required.
§ Knowledge of radiation survey meters a plus
§ Experience in diagnosis and repair of equipment failures required.
§ Experience with high voltage training preferred.
§ Knowledge of basic cGMP practices and procedures a plus.
§ Ability to define problems, collect data, establish facts, and draw valid conclusions required.
§ Experience working with radioactive materials a plus.
§ Ability to climb ladder 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.
§ Ability to work independently.
§ Experienced in Microsoft Suite required.
§ Travel:
up to 20%.
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