Manufacturing Associate Level 1

Job Title: Manufacturing Associate -
Job ID: 26-03802
Location: Walkersville, MD, 21793
Duration: 12 Months

Shift Details:

• Schedule is Monday through Thursday, 6:30 AM to 5:00 PM.
• Arrive at 6:30 (or earlier) for the daily briefing meeting, then gown for the day. Occasionally, workers will need to arrive early and be gowned by 6:30 but notice will be provided, and there may be occasional OT.

Summary

• Responsible for performing production functions in a Powder or Liquid Media manufacturing facility according to company and departmental SOP's.
• The individual will maintain records to comply with Good Manufacturing Practices and Standard Operating Procedures.
• The individual will work in a fast-paced, safety-oriented, team environment

• 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 training
• Maintain accurate production bin inventory in responsible area.
• Provide information related to deviations to support investigations
• Being available for business-necessitated overtime is required
• Perform other duties as assigned.

Education:

• Diploma or GED
• Bachelor's Degree preferred
• Strong manufacturing or technical skills required