Pharmaceutical Manufacturing Operator

Pharmaceutical Manufacturing Operator

Direct Hire Full-Time Role

Pay Rate: $24 - $29 per hour

Location: Janesville, WI - Onsite Role

Job Summary:

We are seeking a 3rd Shift 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. These positions will perform operations with a focus on efficiency, quality, and safety standards while using remote manipulators in cleanrooms to produce Lu-177.

Duties and Responsibilities:

• 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 the direction or supervision of the Manufacturing Engineer.
• Support the 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 the training and development of other technicians.
• Assist other projects and departments and perform other duties as requested or assigned.

Requirements and Qualifications:

• 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 of experience or a 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.
• The position will require non-standard work hours and shift work, on a periodic, rotational, or ongoing basis. Overtime may sometimes be necessary to complete the required work assignment with little or no advance notice.
• Some travel may be required.

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