Cyclotron Engineer - On Site

About the role

PharmaLogic is the fastest-growing SPECT & PET radiopharmaceutical solutions provider and contract development and manufacturing organization (CDMO) with radiopharmacies across North America. We are passionate about expanding the power of radiopharmaceutical technology to provide transformative diagnostic and therapeutic agents to patients from bench to bedside.

Responsibilities

• Maintains a favorable working relationship with coworkers to promote a cooperative working climate conducive to maximum productivity, efficiency and effectiveness
• Works with radioactive materials and follows all applicable procedures and regulations for maintaining ALARA practices
• Ensures completion of required equipment, maintenance and calibration
• Brings to Quality and operations manager’s attention any product or component release problems and awaits management resolution if required
• Documents, investigates and reviews any out of specification (OOS) or deviations as part of GMP compliance as it relates to engineering tasks
• Coordinates with Facility Manager to schedule annual and additional preventive maintenance and associated production downtime
• Follows good documentation practices at all times when documenting QA documents
• Adheres to Company policies and procedures at all times
• Liaises with Quality Manager to ensure any issues are addressed in a timely manner
• Completes all planned Quality & Compliance training within the defined deadlines
• Ensures safe work procedures and wears all required PPE
• Prompts reports all injuries and unsafe conditions
• Supervises and/or assists in the operation and maintenance of the PET cyclotron
• Supervises and/or assists in the preparation of PET isotopes and radiopharmaceuticals, including FOG
• Maintains all required documents and records
• Participates in the installation of equipment and has technical responsibility over the Cyclotron subsystem during the Installation/Commissioning phase
• Operates the cyclotron according to proper operating procedures during the Operations/Maintenance phase
• Performs routine, non-routine, and emergency maintenance on the cyclotron
• Maintains essential parts on site for cyclotron, manipulator arms and chemistry modules
• Ensures completion of documentation related to cyclotron operations
• Performs diagnosis and repair on electronic equipment, programmable logic controllers, power supplies, high voltage and high-power RF systems
• Provides after-hours on-call support, including nights, weekends, and some holidays for maintenance and emergency support
• Maintains and troubleshoots automated chemistry processing equipment
• Designs and builds equipment to improve diagnostic and repair capabilities and implement reliability improvements for cyclotron and isotope manufacturing
• Designs, develops and builds radioisotope production and chemical processing equipment
• Assures compliance with all procedures, regulations, organizations, etc.
• Participates in department technical training
• Performs trend analysis and tracking of production systems performance data
• Provides cyclotron operation coverage when required by the schedule
• Performs routine, non-routine, and emergency maintenance of general laboratory equipment

Requirements

• Completion of manufacturer’s applications training course for the cyclotron and chemistry modules
• Experience in PET manufacturing, pharmaceutical manufacturing (FDA and GMP regulated), nuclear pharmacy, chemistry training or comparable laboratory background preferred
• Bachelor’s degree in science preferred or technical degree, electronics military training or equivalent experience
• Knowledge of cGMP and NRC regulations preferred
• Strong interpersonal skills with an emphasis on effective communication and proven ability to interact effectively with stakeholders in a diverse population at all levels
• Computer proficient, including knowledge of Microsoft Office (Word, Excel, Outlook)
• Demonstrated organizational skills with the ability to manage time effectively in a fast-paced environment and a high volume of work
• Analytical and problem-solving skills
• Ability to accommodate shift changes based on business needs
• Authorized user of radioactive material required
• Knowledge of aseptic technique

Physical and Intellectual Requirements

• Mechanical aptitude; manual dexterity for manipulating small items; ability to lift between 16 to 50 lbs. and to handle frequent crawling, stooping, crouching and kneeling
• Ability to analyze situations, set priorities and meet deadlines while maintaining attention to detail in a fast-paced and dynamic environment; effective organizational skills; a commitment to continuous learning
• Ability to work well both independently and as part of a team
• May require travel up to 25%

Benefits

• 401(k) retirement benefit program
• Medical and dental care
• Disability insurance
• Employee assistance program
• Extended health care
• Life insurance
• Paid time off
• Vision care