Pharmaceutical Manufacturing Technician - 2nd Shift

SHINE; Janesville (WI); Presencial; USD 34.000 - 44.000; Jornada completa

Descripción de la vacante

SHINE Technologies, LLC in Wisconsin is seeking a Pharmaceutical Manufacturing Technician for the 2nd shift to produce Lu-177 in cleanrooms using remote manipulators, focusing on quality, safety, and efficiency. The role involves handling materials, maintaining records, and supporting continuous improvement while complying with regulatory standards and training requirements.

A strong foundation in cGMP and radiation safety is required, with an associate degree or an equivalent combination of

Formación

• Associate degree plus 1 year experience, or high school diploma with 2+ years in pharma/API.
• Experience drafting SOPs and batch records.
• Familiarity with cGMP/cGDP and radiation safety.

Responsabilidades

• Maintain batch records and related documents per cGMP/cGDP.
• Prepare materials for Lu-177 manufacturing; cleanrooms and aseptic processes.
• Perform production tasks: receiving materials, processing radioisotopes, shipping API.
• Conduct routine maintenance under supervision.
• Identify opportunities for process improvements.
• Keep work areas clean and safe.
• Document maintenance, investigations, and changes in the QMS.
• Assist in writing deviations and training other technicians.
• Adhere to cGMP at all times.
• Support other projects and departments as needed.

Conocimientos

Math & algebra

SOP/documentation

Procedural compliance

Radiation safety

Engineering drawings

Educación

Associate degree + 1 year experience

High school diploma + 2+ years experience

Herramientas

QMS

Descripción del empleo

Description

SHINE Technologies is seeking a Pharmaceutical Manufacturing Technician – 2nd Shift, 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. The Pharmaceutical Manufacturing Technician will perform operations with focus on efficiency, quality and safety standards while using remote manipulators in cleanrooms to produce Lu-177.

2nd Shift Schedule:

Monday 8:00am - 6:00pm

Tuesday 10:00am - 8:00pm

Wednesday 3:00pm - 3:00am

Thursday 1:00pm - 9:00pm

Friday - OFF

The base salary range for this position is $25.00 - $32.00 per hour plus a comprehensive compensation package. Our salary ranges are determined by role, level, and location.

Duties and Responsibilities:

All below listed responsibilities must be completed in compliance with federal, state, local, and company-specific regulations related to quality of product, employee and customer safety, and to the proper performance of day-to-day operations. The essential functions of this position include, but are not limited to:

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

Requirements

• 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 experience or 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 required work assignment with little or no advance notice.
• Some travel may be required.

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, LLC maintains affirmative action plans for individuals with disabilities and protected veterans. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Pay Transparency Policy

Employee Rights Under the NLRA

Equal Opportunity Employment

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