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Cyclotron Operations Technician

2 months ago

Somerset, United States SOFIE Full time

Position Title: Cyclotron-Engineering Technician

Department: Technical Services

Reporting To: Field Service Engineer

Overview

The Cyclotron-Engineering Technician is responsible for the secure and routine management, upkeep, and repair of apparatus in SOFIE's PET radio pharmacy, which produces PET diagnostics in accordance with 21 CFR 212 regulations. This role primarily involves first-line troubleshooting, maintenance, and repair of electro-mechanical systems linked to production, including manipulator arms, lead-shielded hot cells, radiosynthesizers, cyclotrons, and their associated subsystems. The individual must possess independent decision-making skills for most site and facility scenarios and will be tasked with resolving non-standard manufacturing issues.

Key Responsibilities

1. Conduct routine, non-routine, scheduled, and emergency maintenance on the cyclotron(s).

2. Complete documentation related to maintenance tasks following work instructions, including preventative maintenance, repair, and audit logs.

3. Plan and execute maintenance activities based on schedules set by the Technical Services management team.

4. Diagnose and repair various systems, including electronic equipment, electro-pneumatic systems, high vacuum systems, and deionized chilled water systems.

5. Provide timely updates to supervisors regarding equipment operation and status.

6. As a primary support, maintain and repair all PET manufacturing equipment at the facility, including lead-shielded hot cells and radiosynthesizers.

7. Collaborate with the Facility Manager to oversee the work of third-party contractors on manufacturing-related equipment.

8. Perform radiation safety duties in compliance with SOFIE's Radiation Compliance/Environmental Health and Safety Program to ensure adherence to all regulations.

9. Ensure compliance with all procedures and regulations under the Quality Assurance program, including participation in exception document reporting.

10. Provide technical training and support to fellow employees.

11. Operate the cyclotron(s) according to established procedures when manufacturing schedules necessitate (may include night and weekend shifts).

12. Offer after-hours on-call support as required.

13. Submit all work tickets, time cards, and expense reports promptly.

14. Perform additional duties as assigned.

Qualifications

1. Associate's degree in engineering technology or a minimum of 2 years of experience as an electro-mechanical technician.

2. Military training/experience is advantageous.

3. Familiarity with digital and analog circuitry is beneficial.

4. Ability to troubleshoot electronics down to the component level is preferred.

5. Proficiency in reading and interpreting mechanical and electrical schematics is required.

6. Expert use of hand tools is necessary.

7. Previous experience in hazardous environments is required.

8. Knowledge of lockout/tagout processes is essential.

9. Familiarity with radiation survey meters is a plus.

10. Experience in diagnosing and repairing equipment failures is required.

11. High voltage training experience is preferred.

12. Understanding of basic cGMP practices and procedures is beneficial.

13. Ability to identify problems, gather data, establish facts, and draw valid conclusions is required.

14. Experience working with radioactive materials is a plus.

15. Capability to climb ladders and stairs, work in protective clothing, operate in confined spaces, and lift a minimum of 50 lbs is required.

16. Occupational exposure to ionizing radiation is necessary.

17. Excellent communication skills, attention to detail, and reliability are essential.

18. Ability to work independently is required.

19. Proficiency in Microsoft Suite is necessary.

20. Willingness to travel up to 20% is expected.