Pharmaceutical Manufacturing Technician - 2nd Shift

ISPE International; Janesville, Northern (WI, KY); Hybrid; USD 52,000 - 67,000; Full time

Job summary

SHINE Technologies is seeking a Pharmaceutical Manufacturing Technician on the 2nd shift to produce Lu-177 and support the growth of our clinical and commercial operations. The role emphasizes quality, safety, and efficiency in cleanrooms and hot cells.

The incumbent will maintain batch records, prepare materials for aseptic production, and support continuous improvement while complying with regulatory requirements. Overtime and occasional travel may be required.

Qualifications

• Associate degree or equivalent experience in pharmaceutical manufacturing.
• Strong understanding of cGMP/cGDP and regulatory compliance.
• Experience with writing deviations and investigations.
• Ability to read engineering drawings or schematics.
• Familiarity with QA systems and batch records.

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.
• Ability to follow and observe all radiation safety and pharmaceutical requirements, including successfully passing all gown qualifications.

Skills

Radiation safety

Gown qualifications

cGMP/cGDP

Mathematics

Documentation (SOPs)

Reading schematics/drawings

Aseptic experience

QMS documentation

Education

Associate degree

High school diploma with 2+ years experience

Job description

Full-time

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.

Shift: Monday - Friday 2:00pm-10:30pm

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.

• 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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