Pharmaceutical Manufacturing Operator

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.
• 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.
• Absorb 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.

Desired Skills and Experience

• Pharmaceutical manufacturing, medical radioisotope production, radiopharmaceuticals, Lutetium-177, Lu-177, active pharmaceutical ingredient manufacturing, API manufacturing, aseptic processing, sterile API preparation, cleanroom operations, remote manipulators, hot cell operations, cGMP, cGDP, batch records, manufacturing documentation, SOP development, raw material handling, material preparation, equipment operation, equipment system checks, line clearance, cleaning procedures, routine equipment maintenance, Quality Management Systems, deviation documentation, investigations, change control, work orders, radiation safety, gowning qualifications, quality compliance, shipping operations, continuous improvement, technician training, mathematical skills, algebra