cGMP Lead Operator - 2nd or 3rd Shift

Company: Shine Technologies Corp
Location: Janesville
Posted on: May 16, 2023

Job Description:

Description: SHINE Technologies is immediately seeking a Lead cGMP Operator for 2nd or 3rd shift. The Lead cGMP Operator will be the lead production operator, working in our cleanrooms to produce our products. This person will use their experience to work with the development team to build robust manufacturing operations and then lead routine production of Lu-177. This individual will help with everything from receiving raw materials, processing radioisotopes in production hot cells, preparing the sterile API and shipping the API to our customers. In addition, this person will help guide design of a new cGMP facility. Starting pay rate of $35-$36 per hour Duties and Responsibilities: Specific duties and responsibilities of the Lead cGMP Operator include, but are not limited to:

• Responsible for production of cGMP products, executing batch records, running equipment
• Develop procedures and draft documents for operations including SOPs, batch records and forms
• Lead the production of radiopharmaceutical product including set-up, operations, and end of production cleaning
• Cleaning and preparation of the cleanrooms
• Aseptically filling and sealing vials
• Assisting in development and validation activities
• Training and mentorship of other manufacturing operations staff
• Assist other projects and departments, as required
• Some travel may be required
• Overtime may sometimes be necessary to complete required work assignment with little or no advance notice Requirements:
  • Degree in engineering or scientific discipline or comparable experience, preferred.
  • Minimum 7 years of equivalent experience, preferred.
  • Pharmaceutical or API manufacturing experience required
  • Radioisotope production experience preferred
  • Aseptic experience preferred
  • Experience drafting documents such as SOPs and batch records 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 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 E-Verify PI216481828

Keywords: Shine Technologies Corp, Janesville , cGMP Lead Operator - 2nd or 3rd Shift, Other , Janesville, Wisconsin