Production Technician

Job Title: Production Technician

Location: Durham, NC

Duration: 12 months

• 2-2-3 rotating schedule:
  
  
  
  • 2 days on, 2 days off
  • 2 days on, 3 days off
  
  
  
  
• Weekly hours vary between 36, 40, and 44 hours
• Must be flexible to work day, evening, overnight, weekend, and holiday shifts
  
  

• Set up and break down GMP manufacturing rooms and equipment.
• Move process materials (up to 50 lbs) accurately and safely following established procedures.
• Ensure compliance with Standard Operating Procedures (SOPs), cGMP regulations, safety guidelines, and government regulations.
• Follow Lean Manufacturing principles and current Good Manufacturing Practices (cGMP).
• Manage inventory and materials required for aseptic manufacturing.
• Prepare, stage, and move manufacturing equipment.

• Operate and monitor manufacturing equipment, including:
  
  
  
  • RCCS
  • Shell Freezers
  • Wheaton Carts
  • Tube Welders
  
  
  
  
• Verify QC status and expiration of sterile equipment.
• Supply materials and provide equipment support during manufacturing operations.
• Utilize manufacturing systems such as:
  
  
  
  • SAP
  • MES
  • Kanban
  • PLC systems
  
  
  
  
• Deliver production samples as required.
• Perform labeling and inventory management of clean and sterile equipment.
• Transfer production samples according to procedures.

• Participate in safety training and compliance activities.
• Maintain accurate documentation and communicate operational information effectively.
• Support continuous improvement and regulatory compliance initiatives.

• Must be able to pass SAM screening.
• Degree in Science or Engineering with 0-1 year of experience, OR
• High school diploma/equivalent with 3+ years of relevant manufacturing experience.
• Basic computer proficiency, including Microsoft Office applications.
• Ability to lift up to 50 lbs.

• Previous experience in a manufacturing or GMP environment.
• Experience working in aseptic, pharmaceutical, biotechnology, or regulated manufacturing environments.