Pharmaceutical Manufacturing Technician

Job Requirements

SHINE Technologies is immediately seeking a Pharmaceutical Manufacturing Technician 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 clean rooms to produce Lu-177.

Base salary range for this position is $20/hour-$35/hour plus a comprehensive compensation package. Our salary ranges are determined by role, level, and location.

• 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.

• Ability to follow and observe all radiation safety and pharmaceutical requirements, including successfully passing all gown qualifications.
• Associate Degree plus a minimum of one year experience or high school diploma with 2 or more years of experience in areas such as pharmaceutical or API manufacturing, equipment operator, and food processing.
• Strong mathematical skills including algebra.
• Experience drafting documents such as SOPs and batch records required.
• Experience working with radioactive materials and/or radioisotope production is a plus.
• Aseptic experience preferred.
• 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.
• Position requires non-standard work hours and shift work, on a periodic, rotational or ongoing basis. Overtime may sometimes be necessary to complete required work assignment with little or no advance notice. Some travel may be required.

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