Production Support Technician - 2nd or 3rd Shift

Company: Shine Technologies Corp
Location: Janesville
Posted on: May 18, 2023

Job Description:

Description: SHINE Technologies is immediately seeking Production Support Technicians to work in our cleanrooms to support the production of Lu-177. This individual will help with everything from keeping track with inventory, receiving raw materials, preparing solutions for the production, preparing the sterile API and shipping the API to our customers. The position as Production Support Technician is an amazing opportunity for someone with a diverse background to join our team and help build our manufacturing operations as we start with clinical production and grow into commercial production. A strong background in pharmaceuticals/APIs or medical devices is required and work with radiopharmaceuticals is preferred. This is a strong team environment and our technician must work well between all departments. This is a fast-paced product development cycle to help cure some life-threatening forms of cancer and we are looking for team members that fit well into this environment. Starting pay rate of $27-$28 per hour Duties and Responsibilities: Specific duties and responsibilities for the Production Support Technician include, but are not limited to:

• Perform inventory management for non-RMS production and cleaning materials.
• Prepare materials/consumables for manufacturing processes.
• Perform aseptic cleaning of the clean rooms.
• Perform system checks on equipment before use in aseptic processes.
• Perform general maintenance and repairs on process equipment.
• Assist with troubleshooting and root cause analysis of component/process failures.
• Onboarding and/or decommissioning cGMP equipment.
• Executing batch records and report any deviations from batch records during batch manufacturing.
• Assisting in development and validation activities.
• Assist other projects and departments, as required
• Writing and/or revising RMS, SOP, and cGMP forms.
• Initiate and author Investigations, Deviations, and Change Control documentation as related to manufacturing of drug product.
• Follow and observe all radiation safety procedures in agreement with regulatory licensing of radioactive material possession and handling.
• Assisting RP/AU in performing daily activity.
• Maintain a clean and safe working environment in compliance with hazardous material safety and pharmaceutical regulation.
• Packages manufactured drug product for shipment.
• Efficiently comply with waste management rules and regulations.
• 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.
  • Minimum 2 years of equivalent experience.
  • Pharmaceutical or API manufacturing experience required.
  • Knowledge of cGMP requirements, aseptic process (cleanrooms environment), and equipment qualification preferred.
  • Efficient in the use of MS Office Suite required.
  • Willingness to learn and understand new technology, instrumentation, and technical processes.
  • Ability to follow written procedures and accurately record test data.
  • Ability to work safely within an industrial and radiation environment.
  • Ability to work multiple or staggered shifts required.
  • Able to lift up to 50 lbs. 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 PI

Keywords: Shine Technologies Corp, Janesville , Production Support Technician - 2nd or 3rd Shift, Professions , Janesville, Wisconsin