SHINE Technologies is seeking a Pharmaceutical Manufacturing Technician - 1st Shift, to perform production of medical radioisotopes and play a major part in growing our manufacturing operations as we start with clinical production and move into commercial production. The Pharmaceutical Manufacturing Technician will perform operations with focus on efficiency, quality and safety standards while using remote manipulators in cleanrooms to produce Lu-177.
Shift: Monday - Friday 6:00am - 2:30pm The base salary range for this position is $25.00 - $32.00 per hour plus a comprehensive compensation package. Our salary ranges are determined by role, level, and location.
Duties and Responsibilities:
- All below listed responsibilities must be completed in compliance with federal, state, local, and company-specific regulations related to quality of product, employee and customer safety, and to the proper performance of day-to-day operations.
- The essential functions of this position include, but are not limited to: Maintain complete and accurate batch records and related documentation in accordance with cGMP/cGDP.
- Prepare materials/consumables for the manufacturing processes of active pharmaceutical ingredient Lutetium Chloride and perform cleaning activities, line clearances, and system checks on equipment before use in aseptic processes.
- Perform production tasks such as receiving raw materials, processing radioisotopes in production hot cells, preparing the sterile API and shipping the API to our customers.
- Perform routine maintenance under direction or supervision of Manufacturing Engineer.
- Support leadership team in identifying operational opportunities for continuous improvement, initiating changes to processes as needed.
- Maintain general cleanliness of work area and assist other work areas as needed to ensure a clean and professional environment.
- Utilize Quality Management System to document maintenance, investigations and change control actions.
- Assist in writing deviations, investigations and initiate unscheduled work orders.
- Strict adherence to cGMP at all times.
- Assist in training and development of other technicians.
- Assist other projects and departments and perform other duties as requested or assigned.
