Pharmaceutical Manufacturing Technician

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

Descripción de la vacante

SHINE Technologies is seeking a Pharmaceutical Manufacturing Technician - 1st Shift to perform production of medical radioisotopes and support our growing manufacturing operations from clinical to commercial production. The role emphasizes efficiency, quality, safety, and aseptic processing in a cleanroom environment using remote manipulators to produce Lu-177.

Responsibilities include maintaining batch records, preparing materials, supporting deviations and investigations, and ensuring strict

Formación

• Experience with cGMP/cGDP documentation and batch records.
• Proficiency in drafting SOPs and batch records.
• Aseptic production experience preferred
• Familiarity with engineering drawings/schematics and test data recording

Responsabilidades

• Maintain complete batch records and related documentation per cGMP/cGDP.
• Operate production tasks in hot cells and prepare sterile API.
• Prepare materials and perform cleaning, line clearances and system checks.
• Assist in writing deviations and investigations, and initiate unscheduled work orders.
• Adhere strictly to cGMP and support continuous improvement initiatives.

Conocimientos

Radiation safety

GMP/compliance

Batch records

SOP drafting

Aseptic operations

Reading drawings

Mathematics

Documentation control

Educación

Associate degree or equivalent

High school diploma with experience

Herramientas

Quality Management System

Descripción del empleo

Description

SHINE Technologies is seeking a Pharmaceutical Manufacturing Technician - 1st 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.

1st Shift Schedule:

Monday - OFF

Tuesday - 6:00am - 4:00pm

Wednesday - 5:00am - 4:00pm

Thursday - 3:00am - 1:00pm

Friday - 6:00am - 3:00pm

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:

• 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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