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

Boehringer Ingelheim; Saint Joseph (MO); On-site; USD 28,000 - 41,000; Full time

Job summary

Boehringer Ingelheim is seeking a production technician to support high-quality biological product manufacturing in the United States. The role emphasizes adherence to GMP, aseptic techniques, documentation, and calibration of production equipment across assigned areas.

Responsibilities include auditing records, following procedures, assisting in new method development, and training staff while maintaining safety and regulatory compliance in a fast-paced production setting.

Qualifications

• Knowledge of GMP/Documentation practices
• Demonstrated ability to work in an aseptic environment
• Ability to train others and follow SOPs
• Must be able to proceed independently using standard methods and aseptic techniques
• Sustained heavy lifting and physical demands as described

Responsibilities

• Prepare, review and audit records, calibration, and documentation for regulatory compliance
• Read and follow schedules, procedures, and documents
• Assist in training other employees in responsibilities
• Operate and troubleshoot production equipment including MES/SAP interfaces
• Maintain equipment calibration schedules and aseptic techniques
• Transfer samples for QC testing and interpret process indicators

Skills

Aseptic techniques

Teamwork

Regulatory compliance

Analytical thinking

Reading schedules/procedures

Communication skills

Physical stamina

Education

High school diploma or equivalent

National Career Readiness Work Keys

Tools

MES

SAP

Scanners

Printers

Scales

Job description

• Perform scheduled preventative maintenance

Description

To perform duties in the manufacturer of high quality biological products.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities

• Prepare, review and audit for completion and accuracy all assigned records, calibration, and documentation in assigned area to ensure regulatory compliance is maintained
• 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 including MES, SAP, scanners, printers, scales and other integrated equipment
• Assist lower labor grades as needed to insure the completion of daily tasks
• Assist validation group perform department equipment validations needed
• Start-up, operate, monitor, maintain, and assist in troubleshooting of all production equipment in assigned department including the EU Building B fillers and all department lyos
• Maintain equipment calibration schedules for routine instruments as defined by SOP’s
• Teach aseptic techniques and monitor others to assure aseptic technique is properly followed in a production environment
• Evaluate and teach the pre-requisites for pre-sterile filling activities, such as but not limited to, component sterilization, verification of component sterilization, equipment cleaning, room cleaning, room monitoring including air flows from HEPA filters, room pressures, set-up, equipment sterilization
• Check the availability of all items required to maintain schedules, procedures, and documentation
• Perform housekeeping and safety inspections and issue reports of said inspections
• Assist in the transfer of new products, new test methods, new production processes, and new technology
• Aseptically gather and transfer samples for QC testing
• Interpret all process indicators, controls, and PLC controllers in assigned department
• Monitor the status of bio-security and recommend improvements
• Perform filter integrity testing and prepare accurate documentation
• Perform scheduled preventative maintenance
• Assist technician 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.
• Other duties as assigned

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. Shall have an adequate knowledge of Drug and Chemical names, and be able to distinguish between similar names, physical appearance and precautions in handling.
• Must be able to proceed independently in product processing in accordance with standard methods, standard operating procedures, and Manufacturing Directions, using proper aseptic techniques

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. Shall have an adequate knowledge of Drug and Chemical names, and be able to distinguish between similar names, physical appearance and precautions in handling.
• Must be able to proceed independently in product processing in accordance with standard methods, standard operating procedures, and Manufacturing Directions, using proper aseptic techniques

Requirements

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
  • Totes are no longer used. Bundles weigh <20#
• High school diploma or equivalent

Our Company

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.

Why Boehringer Ingelheim?

With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Want to learn more? Visit https://www.boehringer-ingelheim.com