Union Central Services Non EU Operator LG4 2nd shift Mon-Fri 2:30pm-11:00pm

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, diversity and inclusion, 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.
• Maintain and operate laboratory equipment, such as but not limited to, pH meters, integrity testing units, Operator Interface Terminals (OIT), and HMI’s.
• Operate and maintain all laboratory and production equipment including monitoring and properly interpreting all indicators, controls, and PLC controllers.
• Assist in troubleshooting equipment problems.
• Perform filter integrity testing and prepare accurate documentation.
• Calibrate pH controllers.
• Prepare, sterilize, media, 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) and steam docking procedures.
• Set-up filters for sterilization.
• Maintain production vessels such as but not limited to pressure hold test, change O rings, inspect valves, inspect agitator bearings.
• Perform other production related aseptic processes as required.
• Maintain inventory of materials to insure production needs are met.
• Practice aseptic techniques independently.
• Assist validation group perform department equipment validations needed
• Perform clean room gowning and pass clean room gowning validation consecutively.
• Clean, assemble, and set-up for sterilization items required for Production.
• 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

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

• 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
  • 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