Senior Biotech Process Engineer - On-Site Change Leader

GMP Pros®; Lincoln (NE); On-site; USD 120,000 - 160,000; Full time

Job summary

GMP Pros® seeks a seasoned Process Engineer to support manufacturing and packaging in a biotech/pharma setting. This hands-on role troubleshoots in real time with operators and leads validation and project engineering activities to drive reliable, compliant processes.

The ideal candidate has 10–15 years in FDA-regulated environments, plus SME-level knowledge of biological processes and aseptic filling. On-site, full-time work in Lincoln, NE is expected.

Qualifications

• 10–15 years of process engineering experience in FDA-regulated manufacturing environments.
• Demonstrated change leadership – earn trust on the plant floor and guide teams through change.
• SME-level knowledge of Biological processes, including aseptic filling.

Responsibilities

• Provide process engineering support across production processes.
• Troubleshoot process and equipment issues directly with operators, mechanics, supervisors, and technical teams.
• Lead or support investigations, root cause analysis, and corrective actions tied to deviations or process failures.
• Support validation activities, continued process verification, process monitoring, and change implementation.
• Partner with QA, QC, Maintenance, Engineering, and Operations to keep processes controlled and reliable.
• Support line trials, startup/ramp-up, and technical improvements tied to throughput, quality, reliability, and waste reduction.
• Bridge upstream manufacturing with downstream packaging performance to solve issues at the source.
• Own Project Engineering scope across the full lifecycle – URS/spec quality, supplier identification, IOQ/PQ, and installation activity.

Skills

Process engineering

Change leadership

Troubleshooting

Biotech knowledge

Aseptic filling

Education

Bachelor’s degree in Chemical/Mechanical/Industrial Engineering

Tools

SAP

MES

Power BI

Job description

GMP Pros® seeks a seasoned Process Engineer to support manufacturing and packaging in a biotech/pharma setting. This hands-on role troubleshoots in real time with operators and leads validation and project engineering activities to drive reliable, compliant processes.

The ideal candidate has 10–15 years in FDA-regulated environments, plus SME-level knowledge of biological processes and aseptic filling. On-site, full-time work in Lincoln, NE is expected.