Process Engineer

Commissioning Partners LLC.; Wilson (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

Commissioning Partners LLC in North Carolina seeks an experienced Process Engineer to support pharmaceutical manufacturing processes, equipment, and technology transfer. You will help optimize operations, develop process documentation, and contribute to qualification activities.

The role requires at least 3+ years in regulated manufacturing, a relevant engineering degree, and strong problem-solving skills to ensure quality, yield, and compliance with FDA and site procedures.

Qualifications

• Bachelor's degree in Chemical, Mechanical, Biochemical, Pharmaceutical, or related engineering.
• 3+ years of pharmaceutical, biotechnology, or regulated manufacturing experience.
• Experience with pharmaceutical manufacturing processes and process equipment.
• Knowledge of process validation, PPQ, technology transfer, and GMP requirements.
• Strong troubleshooting, analytical, and problem-solving skills.
• Experience with PFDs, P&IDs, process equipment, and engineering documentation.
• Experience with upstream, downstream, formulation, fill-finish, or other pharmaceutical manufacturing processes is a plus.

Responsibilities

• Provide engineering support for pharmaceutical manufacturing and process operations.
• Support process development, optimization, scale-up, technology transfer, and process improvement activities.
• Troubleshoot process and equipment issues affecting quality, yield, throughput, and production performance.
• Develop and review process flow diagrams, P&IDs, process descriptions, equipment specifications, and technical documentation.
• Support equipment selection, installation, commissioning, startup, and qualification.
• Participate in process validation, PPQ, engineering runs, and manufacturing readiness activities.
• Support deviations, investigations, CAPA, change controls, and root cause analysis.
• Collaborate with Manufacturing, Quality, Validation, Maintenance, Automation, Engineering, and external vendors.
• Support technology transfer and implementation of new processes and equipment.
• Develop technical reports, SOPs, process documentation, and engineering deliverables.
• Ensure process engineering activities comply with cGMP, FDA requirements, and site procedures.

Skills

Troubleshooting

Analytical skills

Problem solving

Cross-functional collaboration

Education

Bachelor's degree in Chemical, Mechanical, Biochemical, Pharmaceutical, or related Engineering

Job description

We are looking for an experienced Process Engineer to support pharmaceutical manufacturing processes, equipment, process optimization, technology transfer, and validation activities.

Responsibilities:

• Provide engineering support for pharmaceutical manufacturing and process operations.
• Support process development, optimization, scale-up, technology transfer, and process improvement activities.
• Troubleshoot process and equipment issues affecting quality, yield, throughput, and production performance.
• Develop and review process flow diagrams, P&IDs, process descriptions, equipment specifications, and technical documentation.
• Support equipment selection, installation, commissioning, startup, and qualification.
• Participate in process validation, PPQ, engineering runs, and manufacturing readiness activities.
• Support deviations, investigations, CAPA, change controls, and root cause analysis.Evaluate process performance and identify opportunities for improved efficiency, reliability, capacity, and cycle time.
• Collaborate with Manufacturing, Quality, Validation, Maintenance, Automation, Engineering, and external vendors.
• Support technology transfer and implementation of new processes and equipment.
• Develop technical reports, SOPs, process documentation, and engineering deliverables.
• Ensure process engineering activities comply with cGMP, FDA requirements, and site procedures.

Qualifications:

• Bachelor's degree in Chemical, Mechanical, Biochemical, Pharmaceutical, or related Engineering discipline.
• 3+ years of pharmaceutical, biotechnology, or regulated manufacturing experience.
• Experience with pharmaceutical manufacturing processes and process equipment.
• Knowledge of process validation, PPQ, technology transfer, and GMP requirements.
• Strong troubleshooting, analytical, and problem-solving skills.
• Experience with PFDs, P&IDs, process equipment, and engineering documentation.
• Experience with upstream, downstream, formulation, fill-finish, or other pharmaceutical manufacturing processes is a plus.