Manufacturing Engineer- Biotechnology

Responsible for manufacturing engineering activities related to all biological products, corrective and preventative actions related to manufacturing non-conformances / issues, documentation, cost reduction, interface with engineering, development, quality, product management, and service, and training of manufacturing personnel. Supports LEAN culture focusing on standardization, quality, improved performance and increased throughput.Job duties to include but are not limited to;Managing high-throughput, large scale cell culture expansionsDevelop, maintain and improve processes and test protocols for biosensor and finished goods manufacturing which comply with cGMP practices.Create and maintain manufacturing job test procedures, work instructions, and master process documents.Maintain master material data in SAP for all biological products, including component product data, bills of materials and production routings. Determine reagent and inventory needs to maintain cell culture operationsPrimary liaison with Development and Engineering teams on new products and engineering issues.  This includes but is not limited to performing validation testing on new and updated products and processes and implementing these changes in productionDevelop, improve, and implement cGMP practices in biotechnology lab settingsPerform root cause analysis (RCCA) for issues related to biological products and implement effective corrective and preventive actionsComplies with and ensures department compliance with all Company, policies and procedures.