Engineering Technician / Cyclotron Support Engineer

FULL TIME / DIRECT HIRE w/Benefits.

2nd / 3rd Shift. Flexible work hours, need to be available for cyclotron start up and for potential repairs as needed.

Responsibilities:

• The Engineering Technician prime responsibility is the installation, maintenance, repair and continuous improvement of all process equipment (manufacturing and packaging) and building/facility systems in accordance with instruction manuals, drawings, SOPs, GMPs and safety procedures, while focusing on eliminating breakdowns

• The building systems would typically comprise of HVAC, electrical, water, chillers, boilers, compressed air systems

• Serves as primary troubleshooter for all equipment in the facility while ensuring compliance with all acceptable codes, OSHA regulations and safety requirements

• Monitors operations of mechanical, electronic, and electrical equipment and associated components and make adjustments as necessary to ensure proper operation of equipment

• Performs required analysis of all electrical, electronic and mechanical components in the event of equipment failure, determine the cause of any problems/malfunctions, and take corrective action as required

• Performs equipment set-ups as required

• Performs calibrations of instruments and equipment as required

• Responsible for establishing and maintaining inventory of spare parts

• Responsible for establishing and performing preventive maintenance on all equipment to ensure proper operation and minimal downtime

• Responsible for measuring and recording measurements (voltage, amperage, RPM, etc.) and maintaining proper documentation regarding equipment/system performance and maintenance

• Responsible for notifying supervisor or manager regarding equipment performance and maintenance

• Must participate and successfully complete all training as required by the company

• Responsible for overseeing the activities of contractors working on-site and ensuring they are trained on the appropriate procedures and systems, prior to performing work

• Commitment to high level of ownership of safety, hygiene, quality and cGMP practices

• Follows all department SOPs and all applicable company SOPs

• Prepare for and participate in both internal and external safety and cGMP audits

• Assist in developing and revising standard operating procedures

• Responsible for training and development of new and current employee on manufacturing responsibilities including cross-training to maximize departmental knowledge

• Participate in department or company projects/initiatives as requested

• Interact with Operations/Manufacturing, Quality, R&D, Supply Chain, etc

• Perform other plant maintenance functions as required

• Perform other duties as assigned

Qualifications:

• Ability to work independently under pressure in a fast-paced, team oriented, ever-changing manufacturing environment

• Demonstrated trouble shooting ability, excellent attendance and safety record, strong work ethics

• Excellent knowledge of current Good Manufacturing Practices (cGMP’s)

• Working knowledge of all relevant safety procedures within the company

• Excellent understanding of most areas in Manufacturing and supporting functional groups

• Computer literate and proficient with Microsoft Office specifically Word and Excel

• Ability to quickly learn company used applications as required

• Strong organizational skills and the ability to multitask

• Excellent communication and interpersonal skills

• Ability to work evenings, weekends, holidays and on-call

• High School Diploma, Technical School Certificate, knowledge of electronics plus a minimum of 10 years relevant mechanic experience

• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, SOPs, and manuals

• Ability to write routine reports and correspondence

• Ability to speak effectively before groups of customers or employees of organization

• Ability to apply concepts of basic algebra and geometry

• Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume

• Ability to define problems, collect data, establish facts, and draw valid conclusions

• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables

• Required to stand and walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear

• Frequently lift and/or move up to 50 pounds

• Specific vision abilities required by this job may include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus

• Frequently exposed to moving mechanical parts; high, precarious places and risk of electrical shock

Alternative Job Description: Cyclotron Support Responsibilities:

•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 responsibility for first-line troubleshooting, maintenance, and repair of equipment associated with manufacturing, including manipulator arms, lead shielded hot cells, radiosynthesizers, etc

•Operate the cyclotron(s) according to proper operating procedures when 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 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 Company 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