UNION Aseptic Filling Operator LG4 2nd shift Sun-Thur 3:00pm - 11:30pm - Building B

Boehringer Ingelheim • Saint Joseph, MO

6d

About The Position

Perform duties involved in manufacturing high-quality biological products. The role supports the discovery, development, and delivery of products by operating and maintaining production equipment in an aseptic manufacturing environment, while following schedules, procedures, manufacturing directions, and documentation requirements.

The operator prepares, reviews, and audits records for accuracy and regulatory compliance; supports equipment validation, calibration, troubleshooting, and preventative maintenance; and helps train employees in aseptic techniques and assigned procedures. The role also involves preparing production areas and equipment for pre-sterile filling, monitoring room conditions and process controls, collecting samples for QC testing, performing filter integrity testing, and supporting product and process transfers.

This position is classified as Level III. Employees routinely participate in an aseptic qualification program. The work requires sustained heavy lifting over extended periods and the ability to wear a respirator if required, with no pulmonary restrictions.

Requirements

• High school diploma or equivalent.
• Good verbal and written communication skills and the ability to train others.
• Ability to perform calculations and conversions involving weights, volumes, and percentages.
• Ability to use basic logic to identify and solve problems.
• Ability to recognize and implement ideas that improve efficiency, effectiveness, and simplicity.
• Demonstrated understanding of systems, equipment, and processes.
• Experience with the Windows operating system.
• Proficient reading, comprehension, and application skills for a diverse set of complicated tasks.
• Ability to wear a respirator if required, with no pulmonary restrictions.
• Ability to perform sustained heavy lifting over extended periods.
• Ability to pull a pallet of 500 ml bottles weighing 28 pounds on a pallet jack and push it with 34.5 pounds of force.
• Ability to perform a two-person lift of a 43-pound header tank.
• Work-related handling includes cases of 500 ml bottles weighing 11 pounds each; pallets contain 70 cases, with 10 pallets noted.
• Bundles weigh less than 20 pounds.
• Must be able to proceed independently with product processing according to standard methods, SOPs, and Manufacturing Directions using proper aseptic techniques.

Nice To Haves

• Successful completion of the 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 and documentation practices.
• Demonstrated safe working habits and knowledge of 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 applicable federal, state, and international regulations, including cGMP, USDA, DOT, EPA, and OSHA requirements.
• Demonstrated knowledge of corporate guidelines and policies related to the employee's work.
• Adequate knowledge of drug and chemical names, including the ability to distinguish similar names and appearances and understand handling precautions.
• Mechanical aptitude.

Responsibilities

• Prepare, review, and audit assigned records, calibration information, and documentation for completion and accuracy to maintain regulatory compliance.
• Read and follow schedules, procedures, and documents.
• Assist with training employees in the area of responsibility.
• Assist staff in developing new procedures and methods or improving existing ones.
• Use computer-assisted data entry and related equipment, including MES, SAP, scanners, printers, and scales.
• Assist lower labor grades as needed and perform work of a lower classification when required.
• Assist the validation group with department equipment validations.
• Start up, operate, monitor, maintain, and help troubleshoot production equipment, including Building B fillers and department lyophilizers.
• Maintain calibration schedules for routine instruments as defined by SOPs.
• Teach aseptic techniques and monitor others to ensure they are properly followed in production.
• Evaluate and teach prerequisites for pre-sterile filling activities, including component sterilization and verification, equipment and room cleaning, room monitoring, HEPA airflow and room-pressure checks, setup, and equipment sterilization.
• Check availability of items needed to meet schedules and follow procedures and documentation requirements.
• Perform housekeeping and safety inspections and issue inspection reports.
• Assist with transfers of new products, test methods, production processes, and technology.
• Aseptically collect and transfer samples for QC testing.
• Interpret process indicators, controls, and PLC controllers in the assigned department.
• Monitor bio-security status and recommend improvements.
• Perform filter integrity testing and prepare accurate documentation.
• Perform scheduled preventative maintenance.
• Routinely complete an aseptic qualification program.

Benefits

• Competitive compensation and benefit programs.
• Support for a healthy working environment, meaningful work, mobility, networking, and work-life balance.
• Opportunities to collaborate internationally and contribute to company success.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED