Process Engineer

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

• 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?

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

• 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.
• Own Project Engineering scope across the full project lifecycle - maturing URS/specification quality in partnership with the site team, vendor identification and assessment, and equipment installation activities (FAT/SAT, IOQ/PQ) - bridging process and project engineering rather than working in a silo.
• Build the business case for process and capital improvements with quantifiable results (cost savings, capacity gains, risk reduction) to support site funding decisions.

Requirements:

• 10-15 years of process engineering experience in an FDA-regulated or similarly controlled manufacturing environment.
• Demonstrated change leadership – proven ability to earn trust on the floor, guide operators and technical teams through process and organizational change, and sustain momentum without forcing it.
• 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 owning capital/small-cap project scope end-to-end – budget, schedule, design, and construction oversight – while staying grounded in the process itself.
• 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.
• Experience developing the capability of others – mentoring engineers, co-ops, or technicians and elevating team performance over time.

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.