WI3653080

1

Vocational Degree

Associate Degree

Second Shift (Evening)

40

JOB REQUIREMENTS: SHINE Technologies is seeking a 2nd Shift Production
Operator. The person in this role will be the operator, working in our
cleanrooms to do routine production of Lu-177. The Production Operator
individual will help with everything from receiving raw materials,
processing radioisotopes in production hot cells, preparing the sterile
API and shipping the API to our customers. This is an amazing
opportunity for someone with a diverse background to join our team and
help build our manufacturing operations as we start with clinical
production and grow into commercial production. A strong background in
pharmaceuticals/APIs or medical devices is required and work with
radiopharmaceuticals is preferred. This is a strong team environment,
and our operators must work well between all departments. This is a
fast-paced product development cycle to help cure some life-threatening
forms of cancer and we are looking for team members that fit well into
this environment. Duties and Responsibilities: Specific duties and
responsibilities of the Production Operator include, but are not limited
to: Operate, maintain, and report process data from automated and
semi-automated radiopharmaceutical manufacturing equipment Prepare
materials/consumables for manufacturing processes and perform system
checks on equipment before use in aseptic processes. Perform line
clearance and cleaning activities of the hot cell and cleanrooms
Responsible for performing production of cGMP products. Executing batch
records and report any deviations from batch records during batch
manufacturing. Aseptically filling and sealing vials using manipulator
arms Assisting in development and validation activities Assist other
projects and departments, as required Initiate and author
Investigations, CAPAs, Deviations, and Change Control documentation as
related to manufacturing of drug product Follow and observe all
radiation safety procedures in agreement with regulatory licensing of
radioactive material possession and handling Maintain approved gowning
validation and media fill participation to allow access to classified
manufacturing areas Maintain a clean and safe working environment in
compliance with hazardous material safety and pharmaceutical regulation
Packages manufactured drug product for shipment Efficiently comply with
waste management rules and regulations Some travel may be required
Overtime may sometimes be necessary to complete required work assignment
with little or no advance notice \*\*\*\*\* OTHER EXPERIENCE AND
QUALIFICATIONS: Degree in engineering or scientific discipline or
comparable experience Minimum 2 years of equivalent experience
Pharmaceutical or API manufacturing experience required Knowledge of
cGMP requirements, aseptic process (cleanrooms environment), and
equipment qualification preferred Radioisotope production experience
preferred Efficient in the use of MS Office Suite required 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
Ability to work multiple or staggered shifts required Able to lift up to
50 lbs. \*\*\*\*\* APPLICATION INSTRUCTIONS: Apply Online:
https://recruiting.paylocity.com/recruiting/jobs/Apply/2057661/SHINE-Technologies-LLC/Production-Operator\-\--2nd-Shift?source=Job%20Center%20of%20WISC