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HPLC Design Engineer job in Fitchburg at SHINE Technologies, LLC

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HPLC Design Engineer at SHINE Technologies, LLC

HPLC Design Engineer

SHINE Technologies, LLC Fitchburg, WI Full-Time
Description:

This role will involve designing, fabricating, and running HPLC equipment to support experimental design and execution of small scale and production scale chemical processes for Active Pharmaceutical Ingredient (API) process development and API manufacturing process improvement. This role will also lead efforts for production equipment design to include scale up from development to full scale manufacturing. This is a fast-paced product development cycle to help cure some of life-threatening forms of cancer and is looking for team members that fit well into this environment.


Duties and Responsibilities:

Specific duties and responsibilities include, but are not limited to:

  • Design, fabricate/procure, install, and operate preparative HPLC equipment
  • Collaborate with multiple process development teams to support translation of small-scale HPLC-based processes to design requirements and specifications for full-scale production systems and processes
  • Collaboratively develop equipment and process commissioning plans
  • Lead start-up and commissioning of HPLC equipment and processes
  • Troubleshoot equipment problems and develop corrective actions
  • Collaboratively develop and execute equipment qualifications (IQ, OQ, PQ)
  • Develop SOPs, batch records, and technical documents
  • Assists other projects and departments as required
  • Some travel may be required


Requirements:
  • Experience designing, fabricating, and running HPLC equipment. Preparative HPLC equipment experience is highly desired.
  • BS in Chemical/Mechanical/Nuclear Engineering, Chemistry, Radiochemistry or Physics with 10+ years of relevant experience
  • Demonstrated experience with manufacturing within FDA GMP regulatory requirements is highly desired.
  • Experience or knowledge of nuclear process equipment and instrumentation is desired
  • 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

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.


SHINE Technologies is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Pay Transparency Policy

Employee Rights Under the NLRA

Equal Opportunity Employment

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PI197885507

Recommended Skills

  • Api
  • Chemistry
  • Curiosity
  • Design Of Experiments
  • Industrial Production
  • Instrumentation
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Job ID: 3725591765

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