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.
• Perform aseptic processes.
• Operate, monitor, and maintain all production equipment such as, but not limited to, blend tanks, shelf freezer, tubing welder, tubing fuser, and process logic controllers.
• 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.
• Other duties as assigned

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 of complicated tasks.
• Physical Demands
  • MEDIUM LEVEL 3 – Exerting 20 to 50 pounds of force occasionally, and/ or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly.
  • Work related tasks and forces associated:
    • Pushing fat boy 200 tanks, 38 pounds of force; carboy moved w/dolly taking less than 50 pounds of force to move.
    • FREEZER FZB2903 having carts full of antigen 10L bags X 14 on cart, with wheels frozen at -40 degrees (as a one person move, the cart could not be moved AT ALL using a force of 65 pounds), HOWEVER, as a 2 person move it took approximately 45 pounds of force X 2 people to move. THIS IS A 2 PERSON MUST IN THE FREEZER.
  • Ability to wear a respirator as a requirement of the job with 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
• 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.