Manufacturing Engineer - Particle Accelerator

NorthStar’s mission is to transform the medical radioisotopes industry by becoming a global leader of innovative diagnostic & therapeutic medical radioisotopes. In fulfillment of this mission, Northstar has developed a groundbreaking isotope processing methods as well as an instrument/medical device that will efficiently produce important medical Radioisotopes on site at a Radiopharmacy.
NorthStar is in search of a manufacturing/production/industrial engineer that will work with the production equipment design team as well as US National Laboratories on bringing particle accelerator based isotope production systems into production. .
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:

o Execute manufacturing process development of particle accelerator based isotope production systems
o Work directly with product development to develop/execute design transfer plans for new equipment
o Execute manufacturing process development and documentation including work instructions and batch production records.
o Develop scale up/automation of processes development by National Labs.
o Develop test and safety systems in support of production system
o Execute ongoing product & process improvements to meet quality and production goals.
o Execute Factory/Site Acceptance Testing of complex custom equipment
o Develop/execute standards/processes for qualification and process validation
o Analyze and improve material/people flows, process layouts to optimize plant efficiency
o Ensure production equipment is capable and has capacity for growth, involving integrating equipment, people, material flow systems, and information systems.
o Support complaint/event/CAPA/deviation/out of specification investigations
o Prepare cGMP procedures, reports, and plans.

This role may require spending 1-2 days a week in both Beloit or the Madison Engineering Center as required. In addition, the ability to travel internationally and domestically could be required. This is expected to be less than 10% of the time.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Essential Requirements
o Bachelor’s Degree in Engineering from an accredited college or university or equivalent experience.
o Experience with developing material/people flows and process layouts
o Experience developing typical manufacturing processes (mechanical assembly, chemical, fluid transfer)
o Experience executing process validation and documentation activities (IQ/OQ/PQ)
o Note: Level of position will be commensurate with level of experience

• Highly Desired Requirements
o Strong experience in FDA Good Manufacturing Practices (GMP) for either drug or medical device
o Direct experience in a pharmaceuticals and/or medical device manufacturing plant.
o Experience with developing work instructions and batch production or device history records.
o Experience with automating or scaling up manual processes
o Experience with Factory Acceptance Testing of new high value custom equipment
o Experience with process improvement
o Experience with developing material/people flows and process layouts
o Experience in capacity planning

• Preferred Requirements
o Exceptional candidates will have some of the following experiences:
o developing processes in ISO 8 or better clean room environments
o Experience with developing test systems
o Experience in managing GMP equipment including preventive maintenance and calibration programs
o Experience with radioactive materials a plus but not required

• Proficient knowledge of Microsoft Office Suite software programs

• Ability to multi-task, set priorities and meet strict deadlines.
• Using logic and reasoning to offer solutions to problems.
• Thorough understanding of the quality management system.
• Strong organizational and communication skills.
• Mentor others in new processes and procedures.

If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line.



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