Process Engineer - 1099

GMP Pros, Inc.•Omaha, NE

1d•Onsite

About The Position

We are looking for a seasoned, floor-oriented Process Engineer who can support both manufacturing and packaging. This person must be able to troubleshoot in real time with operators, stabilize processes, support validation/change-related activities, understand and support project engineering initiatives (project lifecycle) and bring strong experience in BioTech environments. Be part of an exciting start-up that supports the world’s leading pharmaceutical, biotech, food, and animal health companies. Get the best of both worlds. Gain experience at a company that leads projects for global pharmaceutical companies while enjoying the flexibility, energy, and personal attention that can only be found working in a small, close-knit company.

Requirements

7–10+ years of process engineering experience in an FDA-regulated or similarly controlled manufacturing environment.
Demonstrated SME-level knowledge and experience supporting Biological processes, including aseptic filling.
Strong troubleshooting capability in live production environments.
Experience with deviations, investigations, root cause analysis, change control, and technical process improvement.
Demonstrated experience with the validation lifecycle.
Working knowledge of project engineering principals and proven experience across the project lifecycle.
Comfort working on-site full time and moving between multiple production areas throughout the day.
Ability to work directly with operators and site teams in a practical, hands-on support role.
Bachelor’s degree in Chemical, Mechanical, Industrial, or related Engineering discipline.
Prior experience in Biotech, Pharmaceutical, or Animal Health industries.

Nice To Haves

Experience with line trials, technology transfer, startup support, or new product introduction.
Exposure to continued process verification, FMEA, Lean, TPM, centerlining, or reliability improvement methods.
Experience using plant systems or reporting tools such as SAP, MES, or Power BI.

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, recurring losses, or process failures.
Support validation-related activities, continued process verification, process monitoring, and change implementation as needed.
Partner with QA, QC, Maintenance, Engineering, and Operations to keep processes controlled, reliable, and execution-ready.
Support line trials, startup/ramp-up activities, and technical improvements tied to throughput, quality, reliability, and waste reduction.
Help connect upstream manufacturing conditions with downstream packaging performance so issues are solved at the actual source.
Support Project Engineering across the project lifecycle from URS/specification development to vendor identification and assessment, to equipment installation activities (FAT/SAT, IOPQ).