Pharmaceutical Manufacturing Technician

SHINE Technologies LLC•Janesville, WI

5d•$25 - $32

About The Position

SHINE Technologies is seeking a Pharmaceutical Manufacturing Technician to produce medical radioisotopes, initially supporting clinical production and later commercial production. The role performs manufacturing operations with an emphasis on efficiency, quality, and safety, using remote manipulators in cleanrooms to produce Lu-177. Work includes preparing materials and equipment, processing radioisotopes, preparing sterile active pharmaceutical ingredient (API), documenting work, and supporting continuous improvement and technician training. The role requires compliance with applicable regulations and company procedures, including cGMP requirements. The position involves non-standard work hours and shift work on a periodic, rotational, or ongoing basis; overtime may sometimes be necessary with little or no advance notice, and some travel may be required. The posted first-shift schedule is Tuesday 6:00 a.m.–4:00 p.m., Wednesday 5:00 a.m.–4:00 p.m., Thursday 3:00 a.m.–1:00 p.m., Friday 6:00 a.m.–3:00 p.m., with Monday off. The base salary range is $25.00–$32.00 per hour, plus a comprehensive compensation package.

Requirements

Ability to follow radiation safety and pharmaceutical requirements, including successfully passing gown qualifications.
Associate degree plus at least one year of experience, or high school diploma plus at least two years of experience in areas such as pharmaceutical or API manufacturing, equipment operation, or food processing.
Strong mathematical skills, including algebra.
Experience drafting documents such as SOPs and batch records.
Willingness to learn and understand new technology, instrumentation, and technical processes.
Ability to read engineering drawings or schematics.
Ability to follow written procedures and accurately record test data.
Ability to work safely in an industrial and radiation environment.
Eligibility to qualify for access to information subject to U.S. Export Controls; eligibility may also depend on meeting Nuclear Regulatory Commission requirements for access to Safeguards Information, typically including a pre-employment drug screen, fingerprinting, and criminal background check.

Nice To Haves

Experience working with radioactive materials and/or radioisotope production.
Aseptic experience.

Responsibilities

Maintain complete and accurate batch records and related documentation in accordance with cGMP/cGDP.
Prepare materials and consumables for manufacturing Lutetium Chloride API; perform cleaning, line clearances, and equipment system checks before aseptic processes.
Receive raw materials, process radioisotopes in production hot cells, prepare sterile API, and ship API to customers.
Perform routine maintenance under the direction or supervision of a Manufacturing Engineer.
Support the leadership team in identifying operational improvement opportunities and initiating process changes as needed.
Maintain cleanliness in the work area and assist other work areas to support a clean and professional environment.
Use the Quality Management System to document maintenance, investigations, and change-control actions.
Assist with writing deviations and investigations and initiating unscheduled work orders.
Strictly adhere to cGMP requirements.
Assist with training and developing other technicians.
Assist other projects and departments and perform other duties as requested or assigned.
Complete responsibilities in compliance with applicable federal, state, local, and company-specific regulations related to product quality, employee and customer safety, and day-to-day operations.