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, and process logic controllers (PLCs) including SAP.
• Assist lower labor grades as needed to insure the completion of daily tasks.
• Practice aseptic technique independently.
• Perform media fills (process simulation testing) with passing results per applicable SOP
• Perform clean room gowning and pass clean room garment validation consecutively.
• Prepare disinfectants and sanitizing solutions.
• Ability to independently clean and sanitize production equipment, rooms and areas.
• Perform aseptic operation using laminar flow systems and environmental monitoring.
• Assist in performing environmental monitoring, such as but not limited to, independently placing settling plates and air sampling.
• Set-up, operate, maintain and troubleshoot steam sterilizers, capping machines, Building P sterile fill machines, bottle unscramblers, stoppering machines, tray loaders, bottle washers, sterilizing tunnels, equipment washing machines, sterile filtration equipment, WFI Diluent system, L bar sealers, vision systems, inkjets, automatic bundlers, vacuum check equipment as needed.
• Perform sterile filtration to fill media and stabilizer solutions aseptically with satisfactory results.
• Aseptically gather and transfer samples for QC testing.
• Load and unload freeze driers using appropriate aseptic technique.
• Perform filter integrity and prepare accurate documentation.
• Perform scheduled preventative maintenance.
• Assist higher Grade operators 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.
• All other duties as assigned

Requirements

• Education and/or Experience
  • High school diploma or equivalent
• 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
  • Ability to wear a respirator if required of the job, no pulmonary restrictions.
  • Sustained heavy lifting over extended periods of time.
  • Level III Work related tasks ' weights forces associated:
    • Pallet of 500 ml bottles on pallet jack-28 lbs (pull), 34.5 pounds (push)
    • Header tank weighs 43 pounds and is a 2 person lift.
    • Case of 500 ml bottles-11 lbs, 70 cases per pallet, 10 pallets
    • Bundles weigh <20#

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.
• Adequate knowledge of Drug and Chemical names, and be able to distinguish between similar names, physical appearance and precautions in handling.
• Ability to proceed independently in product processing in accordance with standard methods, standard operating procedures, and Manufacturing Directions, using proper aseptic techniques.