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Manufacturing Technician II

1 month ago

Charlton, Massachusetts, United States LFB USA, Inc. Full time
Job Summary

We are seeking a highly skilled Manufacturing Technician II to join our team at LFB USA, Inc. This role will be responsible for operating and monitoring production equipment, maintaining a clean and safe work environment, and ensuring compliance with Good Manufacturing Practices (cGMPs) and Good Documentation Practices.

Key Responsibilities
  • Equipment Operation and Maintenance: Operate and monitor production equipment, including process tanks, balances, bioburden filtration assemblies, chromatography columns/skids, UF/DF equipment, data recorders, and depth filter systems.
  • Quality Control and Assurance: Demonstrate practical and theoretical knowledge of biomanufacturing concepts and cGMPs, and ensure compliance with quality control and assurance procedures.
  • Materials Management: Weigh and measure raw materials, and prepare buffer solutions for use in bulk manufacturing.
  • Cleanliness and Sanitation: Perform equipment sanitary parts CIP/COP and assist with production equipment maintenance, assembly, and disassembly.
  • Aseptic Operations: Perform aseptic operations, including equipment in-process sampling and work in Laminar Flow Hoods/Biosafety Cabinets, under guidance of senior operator/supervisor.
  • Documentation and Record-Keeping: Complete production records and documentation with strict adherence to cGMPs and Good Documentation Practices.
  • Training and Development: Maintain current status on pertinent standard operating procedures, including in training curriculum, via EQMS/documented training, and support revisions of standard operating procedures.
Requirements
  • Education and Experience: High school diploma or equivalent required; relevant experience in biomanufacturing or a related field preferred.
  • Skills and Knowledge: Strong understanding of biomanufacturing concepts and cGMPs; ability to operate and maintain production equipment; excellent communication and teamwork skills.