cGMP Operator

Company: SHINE Technologies, LLC
Location: Janesville
Posted on: August 7, 2022

Job Description:

Description:
The person in this role will be the operator, working in our cleanrooms to do routine production of Lu-177. This 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 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

Requirements:
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.

Eligibility for employment is conditioned on the applicant's ability to qualify for access to information subject to U.S. Export Controls. Additionally, applicant's eligibility may be conditioned based upon meeting the Nuclear Regulatory Commission requirements for access to Safeguards Information, which typically requires a pre-employment drug screen, fingerprinting and criminal background check.

SHINE values diversity in all its forms as a critical component of innovation, which is fundamental to our success. Every member of the SHINE community benefits from the talents and experiences of our peers, from the mutual respect we exercise, and from the responsibility we take for our actions.

SHINE Technologies is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

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Keywords: SHINE Technologies, LLC, Janesville , cGMP Operator, Other , Janesville, Wisconsin