Process Engineer

Process Engineer

Location: Lincoln, NE (On-site)

Duration: 12 Months (Potential for Extension or Conversion)

About the Role

Join a high-growth company supporting global pharmaceutical, biotech, and animal health leaders. We are seeking a seasoned, hands-on Process Engineer to provide real-time manufacturing and packaging support on the shop floor. This role bridges process optimization, root cause investigations, and full-lifecycle project engineering.

Key Responsibilities

• Shop-Floor Troubleshooting: Partner directly with operators, mechanics, and supervisors to resolve live production and packaging disruptions in real time.
• Process & Quality Support: Lead investigations, root cause analyses (RCA), deviations, and CAPAs; execute formal change controls and process stabilization.
• Full Lifecycle Project Engineering: Own capital and small-cap projects end-to-end—from URS development and vendor assessment to equipment installation, FAT/SAT, and IOQ/PQ.
• Validation & Optimization: Support validation, continued process verification (CPV), line trials, tech transfers, NPI, and throughput/reliability improvements.
• Cross-Functional Bridge: Align upstream bioprocess conditions with downstream packaging performance alongside QA, QC, Maintenance, and Operations.

Requirements

• 7–15 years of Process/Project Engineering experience in FDA-regulated manufacturing (Biotech, Pharma, or Animal Health required).
• SME-level expertise in biological processes and aseptic filling.
• Floor-oriented mindset: Comfortable working full-time on-site across multiple production areas.
• End-to-end capital project experience: Direct ownership of design, URS, FAT/SAT, IOQ/PQ, budget, and scheduling.
• Education: B.S. in Chemical, Mechanical, Industrial, or related Engineering discipline.

Strongly Preferred

• Line trials, startup/ramp-up, or technology transfer experience.
• Exposure to FMEA, Lean, TPM, centerlining, or reliability methods.
• Familiarity with plant tools (SAP, MES, Power BI).