Manufacturing Associate Level 1

Summary:

• Responsible for performing production functions in Powder or Liquid Media manufacturing facility according to company and departmental SOP s.
• Individual will maintain records to comply with Good Manufacturing
• Practices and Standard Operating Procedures.
• Individual will work in a fast-paced, safety-oriented, team environment.
• This is an Aseptic liquid filling role.
• It is manual filling with bottles from 0.2 mils to 1 liter and bags from 1 liter to 20 liters.
• Capping is both Manual and Automated.
• Workers will be required to gown up and work in a cleanroom manufacturing space.
• Workers must be comfortable with basic arithmatic, GMP Documentation, able to lift up to 40 pounds, and maintain a clean workspace.

• Responsible for executing aseptic processing in a clean room environment adhering to Standard Operating Procedures
• Set up and operate production equipment
• Complete documentation concurrently with completion of manufacturing processes
• Responsible for performing personal and environmental monitoring
• Be able to gown aseptically and work in an aseptic environment
• Perform cleaning of production tanks and associated equipment
• Responsible for formulation of bulk productions and stock solutions
• Process production batches in a LFBSC
• Perform integrity testing on all sterilizing filters
• Wrap and assemble filling materials in preparation for autoclaving
• Performs material transfer activities, such as deboxing, disinfectant of cleanroom materials, and transfer for staging
• Assist in drum filling operations when required
• Responsible for completing assigned tasks (for example, cleaning, lab setup, etc.) related to departmental functions
• Ensure general upkeep on equipment and facilities including environmental monitoring
• Review and sign manufacturing batch records and other documentation
• Responsible for keeping current on all job relevant trainings
• Maintain accurate production bin inventory in responsible area.
• Strong manufacturing or technical skills required.

• Diploma or GED (required)
• Bachelor of Science in Science, Engineering or related field (preferred)