Process Validation Engineer in Omaha

Job DescriptionJob Description

Position: Process Validation Engineer

Location: NE (100% Onsite)

Duration: 12+ months

Hours per week: 40

Job Description

Our client is seeking a Process Validation Engineer to support the implementation of a new manufacturing equipment line within a GMP-regulated production environment. This role will focus on process validation, process qualification, and maintaining manufacturing processes in a validated state while supporting manufacturing readiness and equipment startup. Working cross-functionally with Operations, Quality, Engineering, and Maintenance, the engineer will author validation documentation, support qualification activities, and ensure compliance throughout the project lifecycle.

The primary responsibility of this role is independently writing Process Validation protocols and reports with minimal training. In addition, the engineer will support master data entry, traceability documentation, and validation activities for new equipment. Due to aggressive project timelines, the team is seeking someone who can immediately contribute with little onboarding and quickly become a productive member of the project team. Candidates with Oral Solid Dose (OSD) manufacturing experience are highly due to the similarity of the manufacturing processes.

Day-to-Day Responsibilities

·         Independently author Process Validation protocols and final reports for new manufacturing equipment and production lines.

·         Support process qualification and validation activities to maintain manufacturing processes in a validated state.

·         Perform Master Data Entry to support manufacturing and validation readiness.

·         Develop and maintain Traceability Matrices against User Requirement Specifications (URS).

·         Partner with Operations, Engineering, Quality, and Maintenance to support equipment implementation and manufacturing startup.

·         Support change controls, deviations, investigations, and validation documentation within Veeva and ERP systems.

·         Monitor manufacturing processes, troubleshoot process issues, and help maintain product quality and process performance.

·         Assist with validation documentation and other project deliverables throughout the equipment implementation lifecycle.