Contract / Temp to Direct / Direct Hire: Direct Hire
Country: United States
Zip or Postal Code: 53545
SHINE is immediately seeking an FDA (Pharmaceutical) Engineer reporting to the Engineering Manager with a well-rounded background who has a proven capability to learn quickly and remain versatile. The ideal candidate has regulatory and engineering experience in the nuclear medicine industry ensuring adherence to GMP requirements.
This position focuses on validation and generation of engineering designs that must meet FDA (pharmaceutical) requirements while ensuring the safe, efficient, and effective operation of the facility, equipment, and controls required for the production and processing of medical isotopes and fissile solutions. Applicants must have a track record of identifying and implementing engineering solutions within an FDA regulated process. Strong regulatory knowledge of the pharmaceutical industry is also required. Laboratory experience in an FDA environment, and experience in the nuclear industry (NRC) are also desired.
Key responsibilities include developing and/or reviewing design documents to ensure compliance with FDA requirements while also ensuring that the engineering design elements remains intact and efficient. A successful candidate will have proven regulatory skills and proven engineering skills.
We are seeking candidates with at least a Bachelorís degree in mechanical engineering, chemical engineering, nuclear engineering, or a related discipline and a minimum of 5 years of recent engineering/regulatory experience in an FDA regulated industry preferably nuclear medicine and GMP requirements.
Eligibility for employment is conditioned on the applicantís ability to qualify for access to information subject to U.S. Export Controls regulations (U.S. Citizen, U.S. Permanent Resident, Asylee or Refugee). Also, applicantís eligibility may be conditioned based upon meeting the Nuclear Regulatory Commission requirements for access to Safeguards information which typically requires pre-employment drug test, fingerprinting, and a criminal background check.
To apply, please complete our culture survey at http://www.cindexinc.com/c/0F2F23 and separately send a cover letter and resume including salary requirements to firstname.lastname@example.org.
VP of Human Resources
SHINE Medical Technologies
101 East Milwaukee Street, Suite 600
Janesville, WI 53545
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