Manufacturing Engineer

Commissioning Partners LLC.; New Jersey; On-site; USD 90,000 - 120,000; Full time

Job summary

Commissioning Partners LLC is seeking an experienced Manufacturing Engineer to support pharmaceutical production, equipment, and continuous improvement in a GMP-regulated environment.

You will optimize processes, troubleshoot equipment, develop SOPs, and collaborate with Quality, Validation, Maintenance, and Production to ensure compliance and efficiency.

Qualifications

• Bachelor’s degree in Mechanical, Chemical, Industrial, Manufacturing, or related Engineering.
• 3+ years of experience in manufacturing, process engineering, production engineering, or equipment engineering.
• Experience with process troubleshooting, equipment optimization, and continuous improvement.
• Knowledge of Lean Manufacturing, Six Sigma, RCA, CAPA, and change control.

Responsibilities

• Support and improve manufacturing processes, production equipment, and assembly/packaging operations.
• Troubleshoot equipment and process issues to minimize downtime and improve production efficiency.
• Develop and optimize SOPs, work instructions, process specifications, and manufacturing documentation.
• Support equipment installation, commissioning, qualification, and validation activities.
• Analyze production data, downtime, yield, scrap, and process performance to identify improvement opportunities.
• Lead or support Root Cause Analysis (RCA), CAPA, deviation investigations, and corrective actions.
• Implement Lean Manufacturing, Six Sigma, 5S, waste reduction, and continuous improvement initiatives.
• Support IQ/OQ/PQ, process validation, equipment qualification, and change-control activities.
• Develop and maintain process documentation, engineering reports, drawings, and technical records.
• Collaborate with Production, Quality, Maintenance, Automation, Engineering, Validation, and Supply Chain teams.
• Support new equipment, process changes, product transfers, and NPI activities.
• Ensure manufacturing processes comply with GMP, EHS, safety, quality, and regulatory requirements.

Skills

Process troubleshooting

Lean Manufacturing

Six Sigma

Problem solving

Project management

Strong communication

Education

Bachelor’s degree in Mechanical, Chemical, Industrial, Manufacturing, or related Engineering

Tools

CAPA systems

Change control systems

Job description

We are looking for an experienced Manufacturing Engineer to support manufacturing processes, equipment, production operations, and continuous improvement initiatives within a pharmaceutical and regulated manufacturing environment. The ideal candidate will have experience with process optimization, equipment troubleshooting, Lean Manufacturing, validation, documentation, and cross-functional collaboration.

Key Responsibilities

• Support and improve manufacturing processes, production equipment, and assembly/packaging operations.
• Troubleshoot equipment and process issues to minimize downtime and improve production efficiency.
• Develop and optimize SOPs, work instructions, process specifications, and manufacturing documentation.
• Support equipment installation, commissioning, qualification, and validation activities.
• Analyze production data, downtime, yield, scrap, and process performance to identify improvement opportunities.
• Lead or support Root Cause Analysis (RCA), CAPA, deviation investigations, and corrective actions.
• Implement Lean Manufacturing, Six Sigma, 5S, waste reduction, and continuous improvement initiatives.
• Support IQ/OQ/PQ, process validation, equipment qualification, and change-control activities.
• Develop and maintain process documentation, engineering reports, drawings, and technical records.
• Collaborate with Production, Quality, Maintenance, Automation, Engineering, Validation, and Supply Chain teams.
• Support new equipment, process changes, product transfers, and NPI activities.
• Ensure manufacturing processes comply with GMP, EHS, safety, quality, and regulatory requirements.

Required Qualifications

• Bachelor’s degree in Mechanical, Chemical, Industrial, Manufacturing, or related Engineering.
• 3+ years of experience in manufacturing, process engineering, production engineering, or equipment engineering.
• Experience with process troubleshooting, equipment optimization, and continuous improvement.
• Knowledge of Lean Manufacturing, Six Sigma, RCA, CAPA, and change control.
• Experience working with manufacturing documentation and regulated environments.
• Strong analytical, problem-solving, communication, and project-management skills.

Preferred Skills

• Pharmaceutical / Biopharmaceutical Manufacturing
• GMP / GxP / FDA
• Process Validation / IQ / OQ / PQ
• Lean Manufacturing / Six Sigma / 5S
• RCA / CAPA / Deviation Management
• NPI / Process Development / Tech Transfer
• Process Optimization / Continuous Improvement
• Manufacturing & Production Equipment
• SOPs / Work Instructions / Change Control