Process Engineer

Role: Process EngineerLocation: Lincoln, NE (Onsite) Job Description:Seeking a hands-on Process Engineer to support manufacturing and packaging operations in a large biotech facility. This role focuses on real-time troubleshooting, process stabilization, validation support, and continuous improvement—especially in OTC powder and oral solid dose (OSD) environments. Key Responsibilities:· Support manufacturing and packaging processes on the production floor· Troubleshoot equipment and process issues with operators and technical teams· Lead/support deviations, root cause analysis, and corrective actions· Assist with validation, process monitoring, and change control activities· Collaborate with QA, QC, Maintenance, and Operations· Support line trials, startup activities, and process improvements· Align upstream manufacturing with downstream packaging performance Requirements:· 7–10+ years of process engineering experience in FDA-regulated environments· Experience in both manufacturing and packaging operations· Strong troubleshooting and problem-solving skills in live production· Experience with deviations, investigations, and change control· Bachelor’s degree in Engineering (Chemical, Mechanical, Industrial, or related)Preferred:· Experience with OTC powders and OSD manufacturing· Knowledge of process validation, CPV, Lean/TPM, or FMEA· Experience with SAP, MES, or Power BI· Background in startup, tech transfer, or new product introduction