Manufacturing Engineer

Commissioning Partners LLC.; New York (NY); On-site; USD 85,000 - 115,000; Full time

Job summary

Commissioning Partners LLC. in New York seeks a Manufacturing Engineer to support pharmaceutical manufacturing operations, equipment performance, process improvements, and production readiness within a GMP-regulated environment.

You will troubleshoot equipment, help install and qualify new lines, review process documents, and collaborate with Maintenance, Quality, Validation, and Operations to ensure compliance and continuous improvement.

Qualifications

• Bachelor's degree in Mechanical, Chemical, Manufacturing, Industrial engineering.
• 3+ years in regulated pharmaceutical or biotech manufacturing.
• Experience supporting manufacturing equipment and processes.
• Strong troubleshooting and problem-solving skills.
• Knowledge of GMP, change control, deviations, CAPA, and manufacturing documentation.
• Hands-on ability in a manufacturing environment.

Responsibilities

• Provide engineering support for day-to-day pharmaceutical manufacturing operations.
• Troubleshoot manufacturing equipment, process systems, and production issues.
• Support equipment installation, startup, commissioning, and operational readiness.
• Identify opportunities to improve equipment reliability, manufacturing efficiency, throughput, yield, and downtime.
• Develop and maintain manufacturing procedures, work instructions, equipment documentation, and technical reports.
• Support process and equipment changes through change control.
• Investigate manufacturing issues, deviations, and recurring equipment problems and assist with root cause analysis.
• Work with Maintenance, Engineering, Quality, Validation, Automation, and Operations teams to resolve technical issues.
• Support equipment qualification, process validation, and manufacturing readiness activities.
• Review P&IDs, equipment specifications, process documentation, and engineering drawings.
• Support new equipment installation, facility modifications, and capital projects.
• Ensure engineering and manufacturing activities comply with GMP, safety, and site procedures.

Skills

Troubleshooting

Process improvement

GMP knowledge

Equipment commissioning

Documentation

Cross-functional collaboration

Problem solving

Root cause analysis

Hands-on

Validation knowledge

Education

Engineering degree

Job description

We are seeking a Manufacturing Engineer to support pharmaceutical manufacturing operations, equipment performance, process improvements, and production readiness within a GMP-regulated environment.

Responsibilities

• Provide engineering support for day-to-day pharmaceutical manufacturing operations.
• Troubleshoot manufacturing equipment, process systems, and production issues.
• Support equipment installation, startup, commissioning, and operational readiness.
• Identify opportunities to improve equipment reliability, manufacturing efficiency, throughput, yield, and downtime.
• Develop and maintain manufacturing procedures, work instructions, equipment documentation, and technical reports.
• Support process and equipment changes through change control.
• Investigate manufacturing issues, deviations, and recurring equipment problems and assist with root cause analysis.
• Work with Maintenance, Engineering, Quality, Validation, Automation, and Operations teams to resolve technical issues.
• Support equipment qualification, process validation, and manufacturing readiness activities.
• Review P&IDs, equipment specifications, process documentation, and engineering drawings.
• Support new equipment installation, facility modifications, and capital projects.
• Ensure engineering and manufacturing activities comply with GMP, safety, and site procedures.

Qualifications

• Bachelor's degree in Mechanical, Chemical, Manufacturing, Industrial, or related Engineering discipline.
• 3+ years of pharmaceutical, biotechnology, medical device, or regulated manufacturing experience.
• Experience supporting manufacturing equipment and production processes.
• Strong troubleshooting and problem-solving skills.
• Experience with equipment commissioning, qualification, or validation preferred.
• Knowledge of GMP, change control, deviations, CAPA, and manufacturing documentation.
• Ability to work hands-on in a manufacturing environment.