Union APU 3 Production Operator LG3 Mon-Fri 2nd Shift 3pm-11:30pm

Boehringer Ingelheim GmbH; Northern (KY); Hybrid; USD 25,000 - 33,000; Full time

Job summary

Boehringer Ingelheim is seeking a Production Operator for the LG3 Mon-Fri 2nd Shift (3pm-11:30pm). The role focuses on aseptic production, documentation, equipment operation, and adherence to GMP and safety practices.

You will prepare records, follow procedures, assist in training, and help improve processes while operating MES/SAP systems and lab equipment to ensure quality production.

Qualifications

• Good verbal and written communication skills.
• Perform calculations and conversions involving weights, volumes, and percentages.
• Ability to use basic logic to identify and solve problems.
• Demonstrated understanding of systems, equipment, and processes.
• Experience with Windows Operating System.
• Ability to work in a team environment.
• Understanding of operating in an aseptic environment.

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.
• Operate production equipment including monitoring and PLC controls.
• Maintain and operate laboratory equipment as described (spectrophotometer, microscopes, centrifuges).
• Aseptically gather and transfer samples for QC testing.
• Assist higher grade operators and perform tasks of lower grades as needed.
• All personnel will undergo aseptic qualification.

Skills

Verbal & written comms

Math calculations

Problem solving

Mechanical aptitude

Computer skills

Teamwork

Aseptic environment understanding

Education

High school diploma or equivalent

Job description

Union APU 3 Production Operator LG3 Mon-Fri 2nd Shift 3pm-11:30pm

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 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 including MES, SAP, scanners, printers, scales and other integrated equipment.
• Assist lower labor grades as needed to insure the completion of daily tasks.
• Maintain and operate laboratory equipment, such as but not limited to, spectrophotometer, microscopes, centrifuges, pH meters, integrity testing units.
• Operate and maintain all production equipment including monitoring and properly interpreting all indicators, controls, and PLC controllers.
• Assist in troubleshooting equipment problems.
• Assist in performing the bulking of final product and prepare accurate documentation.
• Perform filter integrity testing and prepare accurate documentation.
• Calibrate pH controllers.
• Prepare, sterilize, and dispense media and solutions.
• Perform filter sterilization and heat sterilization operations.
• Sterilize fermentors, tanks, vessels, and equipment using autoclaves, clean-in-place (CIP), steam-in-place (SIP).
• Aseptically dispense fermentation cultures into storage containers and properly identify.
• Set-up filters for sterilization and prepare accurate documentation.
• Perform production sterility testing and prepare documentation.
• Maintain production vessels such as but not limited to pressure hold test, change O rings, inspect valves, and inspect agitator bearings.
• Set-up, operate, clean centrifuges, and prepare accurate documentation.
• Set-up, operate, clean, sterilize UF and MF concentrators, and prepare accurate documentation.
• Set-up, operate, clean, sterilize emulsifiers, and prepare accurate documentation.
• Perform other production related aseptic processes as required.
• Aseptically gather and transfer samples for QC testing.
• Assist higher Grade operators under supervision
• May perform jobs of the lower grades as required
• All personnel will be required to routinely go through an aseptic qualification program to ensure adequate aseptic techniques and behavior.
• Other duties as assigned.

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

• Work related tasks & weights forces associated:
• Empty 800L jacketed tank takes 51.7 lbs break away force moved occasionally.
• Filled 1500L subs are now moved with tow trucks.
• Any sub moving by hand must be done with a minimum of two people if moving assistance devices are not available.
• Various filled wire baskets weighing as much as 44 lbs are handled.
• Carboys weighing 50 lbs are lifted onto carts.
• Ability to wear a respirator as a requirement of the job, no pulmonary restrictions.

• High school diploma or equivalent

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 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.
• 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.