Process Validation Engineer

We are seeking an experienced Process Validation Engineer to support process validation, product quality, and manufacturing validation activities at a facility in Lincoln, Nebraska. The ideal candidate will have a strong background in process validation, statistical analysis, packaging validation, product validation, and Continued Process Verification (CPV).

This role will apply data-driven and statistical methodologies to evaluate process performance, identify variability and trends, and ensure manufacturing processes remain capable, consistent, and compliant with established requirements.

• Develop, execute, and support process validation strategies, protocols, and activities.
• Support Continued Process Verification (CPV) programs, including ongoing process monitoring and performance evaluation.
• Apply statistical methods to analyze manufacturing, validation, and process performance data.
• Support product validation activities and ensure processes consistently meet defined specifications and requirements.
• Develop and execute packaging validation protocols and activities.
• Evaluate process data to identify trends, variability, capability issues, and opportunities for improvement.
• Prepare and review validation documentation, including protocols, reports, data analysis, and validation conclusions.
• Collaborate with Engineering, Manufacturing, Quality, and cross-functional teams to support validation initiatives.
• Ensure validation activities are executed in accordance with applicable procedures, quality standards, and regulatory requirements.

• 5–10 years of relevant industry experience in process validation or a related manufacturing/quality discipline.
• Strong hands‑on experience with process validation.
• Experience applying statistical analysis and data‑driven methods to manufacturing or validation activities.
• Experience with packaging validation.
• Experience supporting product validation activities.
• Hands‑on experience with Continued Process Verification (CPV) and ongoing process monitoring.
• Strong technical writing, analytical, documentation, and cross‑functional collaboration skills.
• Ability to work onsite in Lincoln, Nebraska.