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

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

Description

To perform duties in the manufacture 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, pH meters, integrity testing units, Operator Interface Terminals (OIT) HMI's, and osmometer.
• Operate and maintain all laboratory and production equipment including monitoring and properly interpreting all 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 such as but not limited to pressure hold test, inspect/change gaskets and valves
• Perform, monitor, and assist staff in troubleshooting all media processes.
• Weigh out and prepare production media as needed to meet demands of Production.
• Use and understand computer assisted data entry, including SAP.
• Maintain inventory of raw materials to insure production needs are met.
• Assist validation group perform department equipment validations
• Perform scheduled preventative maintenance.
• Assist higher Grade operators under supervision
• Required to perform work of a lower classification as needed.
• Other duties as assigned.

Preferred Experience, Skills, 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

• 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 are able to be implemented to improve efficiency, effectiveness and reduce complexity for department
• Demonstrated understanding of systems, equipment, and processes
• Experience with Windows Operating System.
• Proficient reading, comprehension and application skills toward a diverse set complicated tasks.

Physical Demands:

• MEDIUM LEVEL 3 - Work related tasks ' weights forces associated: Lifting, push/pull in this dept. does not exceed 50 pounds of force. Lifts include hoppers weighing 25 pounds; carboys are only handled empty; the washer lifts 39 pound lids; 325 tanks using 40 pounds of force to push/pull; trucks w/new wheels taking 20-25 pounds to push/pull; pistons out of fill room are moved around 35 pounds; push/pull of autoclave doors take 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.
• High school diploma or equivalent

Desired Skills, Experience and Abilities

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