Process Engineer

Commissioning Partners LLC.; Boston (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Commissioning Partners LLC. is seeking a Process Engineer to support GMP manufacturing operations, process optimization, troubleshooting, and continuous improvement initiatives.

You will lead process optimization, support validation, tech transfer, equipment qualification, and manufacturing readiness, while collaborating with Manufacturing, Engineering, Quality, Validation, and Maintenance teams to drive quality and efficiency.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Pharmacy, or related field.
• 4+ years of experience in pharmaceutical/biotech manufacturing.
• Strong knowledge of GMP, process validation, troubleshooting, and quality systems.

Responsibilities

• Lead and support process optimization, troubleshooting, and continuous improvement activities.
• Support process validation, technology transfer, equipment qualification, and manufacturing readiness.
• Investigate process deviations and perform root cause analysis, CAPA, and change control.
• Develop and review SOPs, batch records, protocols, and technical documentation.
• Analyze process performance and identify opportunities to improve quality, efficiency, and reliability.
• Collaborate with Manufacturing, Engineering, Quality, Validation, and Maintenance teams.

Skills

Process optimization

Troubleshooting

Root cause analysis

CAPA

Change control

Documentation

Education

Bachelor's degree in Engineering, Life Sciences, Pharmacy, or related field

Job description

We are looking for a Process Engineer to support GMP manufacturing operations, process optimization, troubleshooting, and continuous improvement initiatives.

Key Responsibilities:

• Lead and support process optimization, troubleshooting, and continuous improvement activities.
• Support process validation, technology transfer, equipment qualification, and manufacturing readiness.
• Investigate process deviations and perform root cause analysis, CAPA, and change control.
• Develop and review SOPs, batch records, protocols, and technical documentation.
• Analyze process performance and identify opportunities to improve quality, efficiency, and reliability
• Collaborate with Manufacturing, Engineering, Quality, Validation, and Maintenance teams.

Required Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, Pharmacy, or related field.
• 4+ years of experience in pharmaceutical/biotech manufacturing.
• Strong knowledge of GMP, process validation, troubleshooting, and quality systems.