Process Engineer - 1099 or W-2 in Omaha

Energy Jobline ZR; Omaha (NE); On-site; USD 110,000 - 170,000; Full time

Job summary

Energy Jobline ZR seeks a seasoned Process Engineer to support both manufacturing and packaging in a biotech/pharma setting. The role demands hands-on troubleshooting with operators and a track record in regulated environments.

The ideal candidate will contribute to validation activities, continuous process verification, and cross-functional improvement initiatives across QA, QC, and Operations. On-site presence is required.

Qualifications

• Experience in FDA-regulated manufacturing environments.
• Aseptic filling knowledge.
• Ability to troubleshoot in live production environments.
• Strong project lifecycle experience.

Responsibilities

• Provide process engineering support across production processes.
• Troubleshoot process and equipment issues with operators, mechanics, supervisors, and technical teams.
• Lead investigations, root cause analysis, and corrective actions tied to deviations or process failures.
• Support validation-related activities, continued process verification, and process monitoring.
• Partner with QA, QC, Maintenance, Engineering, and Operations to keep processes controlled and execution-ready.
• Support line trials, startup/ramp-up activities, and technical improvements.

Skills

Process engineering

Troubleshooting

Root cause analysis

QA liaison

Hands-on

Education

Bachelor's degree in Chemical/Mechanical/Industrial Eng

Tools

SAP

MES

Power BI

FAT/SAT

Job description

Job DescriptionJob 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

Essential Duties:

• Provide process engineering support acrossproduction 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, andexecution-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 packagingperformanceso issues are solved at the actual source.
• Support Project Engineering across the project lifecyclefrom 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.
• DemonstratedSME-level knowledge andexperience supportingBiologicalprocesses, 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 thevalidationlifecycle.
• Working knowledge of project engineeringprincipalsand 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

• 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-EmploymentRequirements:

• Pass and maintain pre-employment/contract background check and safety certification, including but not limited to outstanding professional references.
• Subjecttomotorvehiclereportreview.
• Maintainvaliddriver’slicenseandendorsementsasrequiredperposition.
• 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-sitefull-timeat theClientfacility.
• 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.