Union LG4 Central Services EU Operator Mon-Fri 3pm-11:30pm

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, and process logic controllers (PLCs) including SAP.
• Assist lower labor grades as needed to insure the completion of daily tasks.
• Assist validation group perform department equipment validations needed
• Assign Batch Numbers to the appropriate product and Batch Record
• Prepare all assigned records, calculations, and documentation, and accurately post completed Batch Record to the appropriate Shop Packet.
• 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.
• Assist in the transfer of new products, new test methods, new production processes, and new technology.
• Perform filter integrity testing and prepare accurate documentation.
• Calibrate pH controllers.
• Prepare, sterilize, dispense media and 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.
• Set-up filters for sterilization.
• Maintain production vessels such as but not limited to pressure hold test, inspect/change gaskets and valves.
• Perform, monitor, and assist 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.
• Ability to independently clean, prepare, and sterilize production equipment.
• Maintain inventory of raw materials to insure production needs are met.
• Perform scheduled preventative maintenance.
• Assist technician under supervision
• Required to perform work of a lower classification as needed.
• Other duties as assigned.

Requirements

• High school diploma or equivalent.
• 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
• Demonstrated understanding of systems, equipment, and processes
• Experience with Windows Operating System.
• Proficient reading, comprehension and application skills toward a diverse set complicated tasks.
• 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).
• Ability to wear a respirator as a requirement of the job, no pulmonary restrictions.

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.