Production Operator - 3rd Shift

SHINE Technologies is immediately seeking a 3rd Shift Production Operator - cGMP to perform production of medical radioisotopes and grow our manufacturing processes in Janesville, WI. The Production Operator will be working in our cleanrooms to do 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. This 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 operators 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.

Duties and Responsibilities:

Specific duties and responsibilities of the Production Operator include, but are not limited to:

• Operate, maintain, and report process data from automated and semi-automated radiopharmaceutical manufacturing equipment to produce cGMP products.
• Prepare materials/consumables for manufacturing processes and perform cleaning activities, line clearances, and system checks on equipment before use in aseptic processes.
• Create documentation as required for manufacturing drug products.
• Follow and observe all radiation safety and pharmaceutical requirements.
• Receive raw materials and package manufactured drug product for shipment.
• Assist other projects and departments and perform other duties as requested or assigned.
• The position will require non-standard work hours and shift work, on a periodic, rotational or ongoing basis.
• 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
• Radioisotope production experience preferred
• Efficient in the use of MS Office Suite 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
• Ability to work multiple or staggered shifts required
• Able to lift up to 50 lbs.