Process Engineer - 1099 or W-2

GMP Pros, Inc.; Omaha (NE); On-site; USD 95,000 - 120,000; Full time

Job summary

A leading firm in pharmaceutical processes is seeking a Process Engineer to support manufacturing and packaging operations. The role requires significant experience in FDA-regulated environments and includes responsibilities like troubleshooting equipment, leading root cause investigations, and collaborating with various teams to ensure smooth operations. Candidates must possess a Bachelor's degree in a relevant engineering field and have over 7 years of hands-on experience. Proficiency with tools such as SAP and Power BI is strongly preferred.

Qualifications

• 7–10+ years of process engineering experience in FDA-regulated environment.
• Demonstrated experience supporting manufacturing and packaging operations.
• Strong troubleshooting capability in live production settings.

Responsibilities

• Provide process engineering support across manufacturing and packaging.
• Troubleshoot process and equipment issues with operators.
• Lead investigations and corrective actions for process failures.

Skills

Process troubleshooting

Cross-functional problem solving

Agile process support

Communication with operators

Education

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

Tools

SAP

MES

Power BI

Job description

• Does navigating organized chaos – where you're pulled into meetings, solving cross‑functional challenges, and balancing compliance with agility – excite you?
• Does the ideal of balancing strict compliance with agile solutions excite you as you help an organization rapidly become more efficient?
• Are you energized by an environment where you'll juggle everything – from deviations to cross‑functional problem solving – all before lunch?

This is an opportunity to support both manufacturing and packaging projects for a massive pharmaceutical manufacturing facility in the Midwest. This person must be able to troubleshoot in real time with operators, stabilize processes, support validation/change‑related activities, and bring strong experience in OTC powders and oral solid dose (OSD) 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.

Essential Duties

• Provide process engineering support across both manufacturing and packaging operations.
• 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.

Requirements

• 7–10+ years of process engineering experience in an FDA‑regulated or similarly controlled manufacturing environment.
• Demonstrated experience supporting both manufacturing and packaging operations.
• Strong troubleshooting capability in live production environments.
• Experience with deviations, investigations, root cause analysis, change control, and technical process improvement.
• 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

• Direct experience with OTC powder manufacturing operations.
• Direct experience with oral solid dose (OSD) products and associated process/equipment challenges.
• Familiarity with manufacturing and packaging equipment commonly used in powder and OSD environments.
• Experience with line trials, technology transfer, startup support, or new product introduction.
• Experience with process validation lifecycle execution, continued process verification, FMEA, Lean, TPM, centrelining, 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.