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Union Aseptic Filling Operator Lg3 1st Shift Tue-Sat 6:00am To 2:30pm - Building B
Posted on May 27, 2025
- Saint Joseph, United States of America
- 40228.0 - 67957.0 USD (yearly)
- Full Time

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Duties & Responsibilities
- Prepare all assigned records, calculations, and documentation.
- Read and follow schedules, procedures, and documents.
- Assist in training other employees in an area of responsibility as assigned.
- Assist staff in developing new procedures and methods or improving old ones.
- Use and understand computer assisted data entry, and process logic controllers (PLCs) including SAP.
- Assist lower labor grades as needed to insure the completion of daily tasks.
- Practice aseptic technique independently.
- Perform media fills (process simulation testing) with passing results per applicable SOP
- Perform clean room gowning and pass clean room garment validation consecutively.
- Prepare disinfectants and sanitizing solutions.
- Ability to independently clean and sanitize production equipment, rooms and areas.
- Perform aseptic operation using laminar flow systems and environmental monitoring.
- Assist in performing environmental monitoring, such as but not limited to, independently placing settling plates and air sampling.
- Set-up, operate, maintain and troubleshoot steam sterilizers, capping machines, Building P sterile fill machines, bottle unscramblers, stoppering machines, tray loaders, bottle washers, sterilizing tunnels, equipment washing machines, sterile filtration equipment, WFI Diluent system, L bar sealers, vision systems, inkjets, automatic bundlers, vacuum check equipment as needed.
- Perform sterile filtration to fill media and stabilizer solutions aseptically with satisfactory results.
- Aseptically gather and transfer samples for QC testing.
- Load and unload freeze driers using appropriate aseptic technique.
- Perform filter integrity and prepare accurate documentation.
- Perform scheduled preventative maintenance.
- Assist higher Grade operators under supervision
- Required to perform work of a lower classification as needed.
- All personnel will be required to routinely go through an aseptic qualification program to ensure adequate aseptic techniques and behavior.
- All other duties as assigned
Requirements
- Education and/or Experience
- High school diploma or equivalent
- Communication Skills
- Good verbal and written communication skills and ability to train others.
- Mathematical Skills
- Perform calculations and conversions involving weights, volumes, and percentages.
- Reasoning Ability
- Ability to use basic logic to identify and solve problems
- Knowledge and skill to recognize creative ideas that add value and are able to be implemented to improve efficiency, effectiveness and reduce complexity for department
- Mechanical Aptitude
- Demonstrated understanding of systems, equipment, and processes
- Computer Skills
- Experience with Windows Operating System.
- Comprehension and application
- Proficient reading, comprehension and application skills toward a diverse set complicated tasks.
- Physical Demands
- Ability to wear a respirator if required of the job, no pulmonary restrictions.
- Sustained heavy lifting over extended periods of time.
- Level III Work related tasks ' weights forces associated:
- Pallet of 500 ml bottles on pallet jack-28 lbs (pull), 34.5 pounds (push)
- Header tank weighs 43 pounds and is a 2 person lift.
- Case of 500 ml bottles-11 lbs, 70 cases per pallet, 10 pallets
- Bundles weigh <20#
Desired Skills, Experience and Abilities
- Additional Education and/or Equivalent Experience
- Successful completion of National Career Readiness Work Keys assessment
- Knowledge of Hazardous Waste Handling
- Knowledge of Decontamination and Sterilization
- Knowledge of Traffic Patterns
- Knowledge of or evidence of working with BPE methods
- Understanding of Basic GMP/Documentation practices
- Demonstrated ability and understanding of Safe working habits and Material Safety Data Sheets (MSDS)
- Understanding of Basic Laboratory Practices, Measurements, Biology and Microbiology
- Understanding of operating in an aseptic environment
- Ability to work in a team environment
- Demonstrated knowledge of Federal, State, and International regulations, such as cGMP, USDA, DOT, EPA, OSHA as they pertain to the employee’s work.
- Demonstrated knowledge of Corporate guidelines and Policies related to the employee’s work.
- Adequate knowledge of Drug and Chemical names, and be able to distinguish between similar names, physical appearance and precautions in handling.
- Ability to proceed independently in product processing in accordance with standard methods, standard operating procedures, and Manufacturing Directions, using proper aseptic techniques.
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