UNION Central Services EU Operator LG4 M-F 7:00am - 3:30pm

Job Title

To perform duties in the manufacture of high quality biological products.

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.

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

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.

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.