UNION Central Services EU Operator LG3 M - F 7:00am - 3:30pm 1st Shift

About the role

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of high-quality biological products to our patients and customers. Our global presence provides opportunities for collaboration internationally, offering visibility and the chance to directly contribute to the company's success.

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 existing 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 ensure the completion of daily tasks
• Maintain and operate laboratory equipment, such as pH meters, integrity testing units, Operator Interface Terminals (OIT) HMIs, and osmometers
• Operate and maintain all laboratory and production equipment, including monitoring and interpreting indicators, controls, and PLC controllers
• Assist staff in troubleshooting equipment problems
• Perform filter integrity testing and prepare accurate documentation
• Calibrate pH controllers
• Prepare, sterilize, and dispense media, solutions, disinfectants, and sanitizing solutions
• Perform filter sterilization and heat sterilization operations
• Sterilize add cans, tanks, vessels, and equipment using autoclaves, ovens, clean-in-place (CIP), steam-in-place (SIP), steam docking procedures, and TOC
• Clean, prepare, and sterilize production equipment
• Set up filters for sterilization
• Perform production sterility testing and prepare documentation
• Maintain production vessels, including pressure hold tests, inspecting/changing gaskets and valves
• Perform, monitor, and assist staff in troubleshooting all media processes
• Weigh out and prepare production media as needed to meet production demands
• Maintain inventory of raw materials to ensure production needs are met
• Assist the validation group in performing department equipment validations
• Perform scheduled preventative maintenance
• Assist higher-grade operators under supervision
• Perform work of a lower classification as needed
• Other duties as assigned

Requirements

• Good verbal and written communication skills and 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
• Knowledge and skill to recognize creative ideas that add value and can be implemented to improve efficiency, effectiveness, and reduce complexity
• Demonstrated understanding of systems, equipment, and processes
• Experience with Windows Operating System
• Proficient reading, comprehension, and application skills for diverse and complicated tasks
• High school diploma or equivalent

Preferred Skills and Qualifications

• Successful completion of National Career Readiness WorkKeys assessment
• Knowledge of Hazardous Waste Handling
• Knowledge of Decontamination and Sterilization
• Knowledge of Traffic Patterns
• Knowledge of or experience 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, ability 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

Physical Demands

MEDIUM LEVEL 3 - Work-related tasks involve weights and forces as follows:

• Lifting, push/pull in this department does not exceed 50 pounds of force
• Lifts include hoppers weighing 25 pounds; carboys handled empty only
• Washer lifts 39-pound lids
• 325 tanks require 40 pounds of force to push/pull
• Trucks with new wheels take 20-25 pounds to push/pull
• Pistons out of the fill room are moved around 35 pounds
• Push/pull of autoclave doors takes 25-30 pounds
• Push/pull of empty sub tank takes 60 pounds (2-person push taking 30 pounds each; full tanks are moved using a machine)
• 2 full ad cans on autoclave cart: 18 pounds push/pull, 19 pounds push/pull on transfer cart
• Ability to wear a respirator as a requirement of the job, no pulmonary restrictions