BFS Manufacturing Engineering Manager

• Lead daily Blow Fill Seal (BFS) production operations by managing resources, setting priorities, and monitoring productivity, equipment utilization, yield, and downtime
• Oversee the setup, operation, maintenance, and troubleshooting of BFS equipment to ensure the efficient production of high-quality sterile products
• Ensure manufacturing processes remain within specifications by managing equipment calibrations, mechanical adjustments, and process performance
• Analyze equipment reliability and operational issues, perform root cause investigations, and implement effective corrective and preventive actions (CAPAs)
• Supervise, train, and coach technicians and operators while ensuring compliance with SOPs, batch records, GMP requirements, aseptic manufacturing standards, and cleanroom protocols
• Partner with Quality, Engineering, Maintenance, and Supply Chain teams to drive continuous improvement, equipment upgrades, preventive maintenance programs, process optimization, and accurate production documentation

Qualification

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, or a related technical field
• Minimum of 2 years of supervisory or team lead experience supporting mechanical engineering activities in a manufacturing or production environment
• Hands-on expertise with Blow Fill Seal (BFS) equipment, processes, and related manufacturing operations
• Strong technical knowledge of industrial machinery and manufacturing systems, with proven ability to troubleshoot equipment issues and implement corrective actions
• Working knowledge of FDA regulations, cGMP requirements, 21 CFR Parts 210/211, and applicable OSHA and EPA standards to ensure compliance and operational excellence