BFS Manufacturing Engineering Manager

ClearBridge Executive Search; Paulsboro (NJ); On-site; USD 85,000 - 125,000; Full time

Job summary

ClearBridge Executive Search in Paulsboro, NJ seeks an hands-on BFS production leader to oversee daily operations for sterile manufacturing. You will manage resources, set priorities, and monitor productivity, yield, and downtime to ensure efficient BFS production.

You will supervise and train technicians, ensure GMP/SOP/batch record compliance and cleanroom standards, and collaborate with Quality, Engineering, Maintenance, and Supply Chain to drive continuous improvement and precise production

Qualifications

• 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.

Responsibilities

• Lead BFS production operations by managing resources, priorities, productivity, and downtime.
• Oversee setup, operation, maintenance, and troubleshooting of BFS equipment for sterile products.
• Ensure processes stay within specifications by calibrations, adjustments, and monitoring performance.
• Analyze equipment reliability, perform root-cause investigations, and implement CAPAs.
• Supervise and train technicians while ensuring GMP, SOPs, batch records, aseptic standards, and cleanroom protocols.
• Collaborate with Quality, Engineering, Maintenance, and Supply Chain to drive continuous improvement and accurate production documentation.

Skills

Leadership

Troubleshooting

Process optimization

CAPA investigations

Documentation & compliance

Education

Bachelor's degree in Mechanical/Manufacturing Engineering or related field

Tools

BFS equipment

Job description

• 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