QA Validation Engineer

Company Info
SHINE Medical Technologies
Janesville, WI, United States

Phone: 6082101071
Web Site:

Company Profile


QA Validation Engineer


Janesville, WI 

Job ID:


Job Description:

An exciting new role in a growing team dedicated to developing non-carrier added lutetium-177 for cancer therapies.  The person in this role will manage a diverse team of engineers and scientists including nuclear, chemical, and automation engineers.  This person will guide the team through design of nuclear separation systems, automated process systems, aseptic operations and facility design.  This is a unique role managing various disciplines working to converge handling of radioactive materials comprised of complex chemistries in a cGMP environment.  Our product is intended for patient administration, so it must be sterile and made according to regulatory requirements.  Our manager will not only guide the team but may be asked to be hands on and work side-by-side with team members in the lab or production space.  A strong background in pharmaceutical process development is required and work with radiopharmaceuticals is preferred.  This is a strong team environment and our manager will be a key contributor to our success.  This is a fast-paced product development cycle to help cure some of life-threatening forms of cancer and we are looking for team members that fit well into this environment.

Duties and Responsibilities:

  • Responsible for a team of development engineers and scientists in the design of processes to produce radioisotopes
  • Develop and maintain schedules and budgets for project ranging from chemical processes to facility construction
  • Responsible for validation programs
  • Lead the design efforts for cGMP production including specification development and drawings
  • Ensure team focus by providing leadership, guidance, and inspiration
  • Develop team and provide mentorship
  • Assist other projects and departments, as required
  • Up to 25% travel may be required
  • Overtime may sometimes be necessary to complete required work assignment with little or no advance notice


  • BS/MS/PhD in engineering or scientific discipline
  • Minimum 10 years of equivalent experience
  • Pharmaceutical process development experience required
  • Radioisotope production experience preferred
  • Experience with equipment qualification and process validation preferred
  • 2+ years management experience required
  • Willingness to learn and understand new technology, instrumentation and technical processes
  • Ability to read from engineering drawings or schematics
  • Ability to follow written procedures and accurately record test data
  • Ability to work safely within an industrial and radiation environment
SHINE Medical Technologies is a nuclear technology company committed to improving the lives of patients around the world. The company is focused initially on the commercialization of medical isotopes. Molybdenum-99 is a diagnostic isotope used to diagnose heart disease, cancer and other diseases. Lutetium-177 is a therapeutic isotope could revolutionize cancer treatment. SHINE’s unique expertise and experience have created isotope production processes that not only will deliver products that help physicians and patients, they will solve critical supply chain problems in the United States, Europe and other global markets. SHINE’s nuclear technology is part of its long-term growth strategy to solve some of humanity’s biggest problems, including the generation of carbon-free energy from nuclear fusion. For more information, please visit our website at

Eligibility for employment is conditioned on the applicant’s ability to qualify for access to information subject to U.S. Export Controls.  Additionally, applicant’s eligibility may be conditioned based upon meeting the Nuclear Regulatory Commission requirements for access to Safeguards Information, which typically requires a pre-employment drug screen, fingerprinting and criminal background check.

SHINE values diversity in all its forms as a critical component of innovation, which is fundamental to our success. Every member of the SHINE community benefits from the talents and experiences of our peers, from the mutual respect we exercise, and from the responsibility we take for our actions.