(Archived) Union APU 3 Production Operator LG3 (M-F 11pm-7:30am)

Description

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, spectrophotometer, microscopes, centrifuges, pH meters, integrity testing units.
• Operate and maintain all production equipment including monitoring and properly interpreting all indicators, controls, and PLC controllers.
• Assist in troubleshooting equipment problems.
• Assist in performing the bulking of final product and prepare accurate documentation.
• Perform filter integrity testing and prepare accurate documentation.
• Calibrate pH controllers.
• Prepare, sterilize, and dispense media and solutions.
• Perform filter sterilization and heat sterilization operations.
• Sterilize fermentors, tanks, vessels, and equipment using autoclaves, clean-in-place (CIP), steam-in-place (SIP).
• Aseptically dispense fermentation cultures into storage containers and properly identify.
• Set-up filters for sterilization and prepare accurate documentation.
• Perform production sterility testing and prepare documentation.
• Maintain production vessels such as but not limited to pressure hold test, change O rings, inspect valves, and inspect agitator bearings.
• Set-up, operate, clean centrifuges, and prepare accurate documentation.
• Set-up, operate, clean, sterilize UF and MF concentrators, and prepare accurate documentation.
• Set-up, operate, clean, sterilize emulsifiers, and prepare accurate documentation.
• Perform other production related aseptic processes as required.
• Aseptically gather and transfer samples for QC testing.
• Perform scheduled preventative maintenance.
• Assist higher Grade operators under supervision
• May perform jobs of the lower grades as required
• All personnel will be required to routinely go through an aseptic qualification program to ensure adequate aseptic techniques and behavior.
• Other duties as assigned.

Requirements

• Good verbal and written communication skills and ability to train others.

• 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.

• Work related tasks & weights forces associated:
• Empty 800L jacketed tank takes 51.7 lbs break away force moved occasionally.
• Filled 1500L subs are now moved with tow trucks.
• Any sub moving by hand must be done with a minimum of two people if moving assistance devices are not available.
• Various filled wire baskets weighing as much as 44 lbs are handled.
• Carboys weighing 50 lbs are lifted onto carts.
• Ability to wear a respirator as a requirement of the job, no pulmonary restrictions.

• High school diploma or equivalent

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 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.
• 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.