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MSAT II, Accelerator Support

NorthStar Medical Radioisotopes

Beloit, WIOnsitePosted 35 days ago
Full TimeMid LevelManufacturing & CMCPharmaceutical
Original posting ↗

Summary

The MSAT II, Accelerator Support is responsible for supporting and executing routine maintenance and repair activities for our particle (electron) accelerators and their supporting systems/equipment. This position will also support the commissioning and installation of accelerators and supporting systems/equipment, as well as the development of procedures for associated maintenance and troubleshooting. This role will provide on-the-floor and standby (on-call) technical support to manufacturing as required.

Job description

Responsibilities

  • Effectively communicate safety and quality issues raised by customers or staff in a timely manner.
  • Support the execution of maintenance, troubleshooting and repairs, and upgrade project work for accelerators and associated support systems.
  • Support the management of spare parts for the accelerators and associated support systems.
  • Develop and author preventative maintenance and troubleshooting procedures for accelerator and supporting systems/equipment.
  • Ensure procedures and work instructions comply with all appropriate safety regulations.
  • Work cross-functionally with other departments to effectively transfer and maintain processes in the facility.
  • Support the evaluation of existing manufacturing processes and maintenance strategies and identify areas for improvement in efficiency, productivity, process capability, risk, and cost reduction.
  • Monitor, trend, analyze, and track performance data of the accelerators and associated support systems.
  • Report and document interventions and actions undertaken with the required level of details and accuracy.
  • Support the development of and provide technical service training for Accelerator Operators and other support personnel.
  • Support the investigation of risk assessments, gap analysis, deviations, change controls, and CAPAs including determination of product or process impact, root-cause analysis, and corrective action identification.

Early Development

After 3 months you will:

  • Achieve Accelerator System Qualification: Complete all required site, radiation safety, GMP, quality, and equipment training.
  • Demonstrate understanding of accelerator theory of operation and supporting systems (vacuum, cooling water, RF, high voltage, pneumatic systems).
  • Successfully qualify for independent access to accelerator support activities under supervision.
  • Become Proficient in Routine Maintenance Activities: Participate in and execute scheduled preventative maintenance tasks on at least one accelerator system.
  • Demonstrate proper use of diagnostic equipment such as DVMs, oscilloscopes, and leak-detection equipment.
  • Complete maintenance documentation accurately and on time.
  • Develop Troubleshooting Competency: Support troubleshooting and repair of at least 3-5 equipment or system issues.
  • Demonstrate ability to interpret electrical schematics, mechanical drawings, and system documentation.
  • Contribute to root-cause identification and corrective actions for equipment performance issues.
  • Establish Operational and Cross-Functional Relationships: Build working relationships with Manufacturing, Engineering, Quality, Radiation Safety, and Maintenance personnel.
  • Participate in shift support and on-floor technical support activities.
  • Demonstrate effective communication of safety, quality, and equipment status issues.

After 6 months you will:

  • Perform Independent Maintenance and Repair Support: Independently execute routine maintenance, troubleshooting, and repair activities on assigned accelerator systems.
  • Serve as a reliable technical resource for manufacturing operations during equipment events.
  • Successfully support on-call or standby activities as qualified.
  • Improve Preventive Maintenance Program: Identify and implement at least one improvement to preventative maintenance procedures or troubleshooting guides.
  • Update documentation to improve equipment reliability, maintainability, or technician efficiency.
  • Utilize Equipment Performance Data to Drive Reliability: Monitor and trend key accelerator and support system performance metrics.
  • Identify recurring equipment issues and recommend corrective actions.
  • Present findings and improvement recommendations to the MS&T Nuclear Engineering team.
  • Lead or Co-Lead a Reliability or Upgrade Project: Take ownership of a small equipment improvement, spare-parts optimization, commissioning, or system upgrade project.
  • Deliver measurable impact to equipment uptime, risk reduction, maintenance efficiency, or cost reduction.
  • Demonstrate ability to work cross-functionally through project completion.

Qualifications

MINIMUM EDUCATION/EXPERIENCE: Bachelor’s Degree in a relevant STEM field and minimum three (3) years of relevant progressive experience within a highly regulated environment; or equivalent combination of education and experience. Relevant military experience will also be considered.

  • Knowledge and experience with the operation of an accelerator, nuclear reactor, or other radiation-producing devices.
  • Ability to understand the detailed theory of operation for most accelerator systems.
  • Working knowledge of digital and analog circuitry.
  • Ability to interpret mechanical and electrical drawings.
  • Working knowledge of various troubleshooting/analysis tools.
  • Proficient use of diagnostic instrumentation and equipment such as DVMs, Oscilloscopes, Micrometers, etc.

PREFERRED EDUCATION/EXPERIENCE: Master’s Degree in a relevant STEM field and minimum two (2) years of relevant progressive experience within a highly regulated environment; or equivalent combination of education and experience.

  • Experience in radiopharmaceutical production.
  • Experience working with accelerators and associated support systems, including electronic equipment, electro-pneumatic systems, high vacuum systems, deionized chilled water systems, high voltage, target, and high-power RF systems.
  • Experience working with helium and ultrasonic leak test equipment.

Requirements

  • Bachelor’s Degree in a relevant STEM field
  • Minimum three (3) years of relevant progressive experience within a highly regulated environment
  • Knowledge and experience with the operation of an accelerator, nuclear reactor, or other radiation-producing devices
  • Ability to understand the detailed theory of operation for most accelerator systems
  • Working knowledge of digital and analog circuitry
  • Ability to interpret mechanical and electrical drawings
  • Working knowledge of various troubleshooting/analysis tools
  • Proficient use of diagnostic instrumentation and equipment such as DVMs, Oscilloscopes, Micrometers, etc.

Benefits

  • Medical, Dental & Vision
  • Healthcare FSA
  • Dependent Care FSA
  • Short-term Disability
  • Long-term Disability
  • Life Insurance & AD&D
  • Pet Insurance
  • 401(k) Matching
  • Paid Holidays
  • Paid Time Off
  • Paid Parental Leave
  • Bonus Plan
  • Equity Incentive Program

Company overview

NorthStar Medical Radioisotopes, LLC is a commercial-stage nuclear medicine company headquartered in Beloit, Wisconsin, with additional facilities in Madison, Wisconsin. Founded in 2006, the company specializes in developing, producing, and manufacturing reliable and environmentally-friendly diagnostic and therapeutic radiopharmaceuticals. NorthStar's mission is to provide patients global access to game-changing radiopharmaceuticals for cancer detection and treatment. The company is the first and only U.S. company housing commercial-scale radioisotope production and radiopharmaceutical CDMO services co-located on the same campus. NorthStar routinely produces therapeutic radioisotopes including copper-67 (Cu-67) and is poised to be one of the first commercial-scale producers of non-carrier-added actinium-225 (Ac-225) using innovative electron accelerator technology. Their FDA-approved diagnostic imaging product, technetium-99m (Tc-99m), is used in 40,000 patient imaging studies daily in the United States. The company also operates a Radiopharmaceutical Contract Development and Manufacturing Organization (CDMO/CMO) unit that provides customized service offerings and specialized radiopharmaceutical expertise to help biopharmaceutical companies advance their development and commercial programs.

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