Senior BioTech Process Engineer — On-Site Change Leader

GMP Pros®

Omaha (NE)

On-site

USD 90,000 - 140,000

Full time

14 days+

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Job summary

GMP Pros® is seeking a seasoned floor-oriented Process Engineer to support manufacturing and packaging in a biotech environment. You will troubleshoot in real time with operators, stabilize processes, and contribute to validation and change projects.

This on-site role requires 10–15 years of FDA-regulated process experience, a chemical/ mechanical/industrial engineering degree, and strong ability to mentor teams while driving continuous improvement.

Qualifications

10–15 years of process engineering experience in FDA-regulated or similarly controlled environments.
Demonstrated change leadership and ability to guide operators and technical teams.
SME-level knowledge in Biological processes, including aseptic filling.
Strong troubleshooting capability in live production environments.
Experience with deviations, investigations, root cause analysis, and change control.
Experience with the validation lifecycle.
Project engineering ownership end-to-end including budget, schedule, design, and construction oversight.

Responsibilities

Provide process engineering support across production processes.
Troubleshoot process and equipment issues directly with operators and technical teams.
Lead or support investigations and corrective actions for deviations or process failures.
Support validation activities, continued process verification, and process monitoring.
Collaborate with QA, QC, Maintenance, Engineering, and Operations to keep processes controlled and reliable.
Support line trials, startup/ramp-up activities, and improvements tied to throughput and quality.
Bridge upstream manufacturing with downstream packaging to resolve issues at the source.
Own project engineering scope across the full lifecycle, from URS to IOQ/PQ.