Process Engineer - 1099 or W-2

GMP Pros®; Omaha (NE); On-site; USD 80,000 - 120,000; Full time

Job summary

GMP Pros® in Omaha, NE is seeking a Process Engineer with 7-10+ years of experience in FDA-regulated environments. The role requires strong troubleshooting skills and expertise in biological processes, focusing on real-time support for manufacturing and packaging operations. Candidates are expected to provide hands-on engineering support, lead investigations, and collaborate with various teams to ensure process reliability. A Bachelor's degree in a related engineering discipline is required. This position is on-site full-time.

Qualifications

• 7-10+ years of process engineering experience in an FDA-regulated or similarly controlled manufacturing environment.
• Strong troubleshooting capability in live production environments.
• Demonstrated SME-level knowledge and experience supporting Biological processes.

Responsibilities

• Provide process engineering support across production processes.
• Troubleshoot process and equipment issues directly with operators.
• Lead investigations and corrective actions tied to deviations.

Skills

Troubleshooting

Process Engineering

Biological Processes

Validation Lifecycle

Project Engineering

Education

Bachelor’s degree in Chemical, Mechanical, Industrial, or related Engineering

Tools

SAP

MES

Power BI

Job description

Job Overview

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.

APPLICANTS MUST HAVE PRIOR EXPERIENCE IN BIOTECH, PHARMACEUTICAL, OR ANIMAL HEALTH INDUSTRIES TO BE CONSIDERED.

Qualities

• Do you find satisfaction in building trust before driving change?
• Do you enjoy helping teams evolve at a pace they can sustain, not just accelerate?
• Can you guide others through change without forcing it?
• Are you comfortable working in environments where relationships matter as much as results?
• Do you take pride in mentoring others and raising the capability of a team over time?

Essential Duties

• 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).

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.

Strongly Preferred

• 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.

Pre-Employment Requirements

• Pass and maintain pre-employment/contract background check and safety certification, including but not limited to outstanding professional references.
• Subject to motor vehicle report review.
• Maintain valid driver’s license and endorsements as required per position.
• Pass pre-employment/contract physical, medical evaluation, and drug screen due to the safety-sensitive nature of this position.
• Successfully complete and maintain any required safety certification and testing on an annual basis.

Work Environment Expectations

• This role is expected to be on-site full-time at the Client facility.
• The individual must be comfortable entering various manufacturing and packaging areas as needed to support operators and troubleshoot issues.
• This is a hands‑on site support role, not a primarily remote or conference-room-based engineering assignment.