Senior Biotech Process Engineer - Onsite & Validation

GMP Pros®; Omaha (NE); On-site; USD 80,000 - 120,000; Full time

Job summary

GMP Pros® in Omaha, NE is seeking a Process Engineer with 7-10+ years of experience in FDA-regulated environments. The role requires strong troubleshooting skills and expertise in biological processes, focusing on real-time support for manufacturing and packaging operations. Candidates are expected to provide hands-on engineering support, lead investigations, and collaborate with various teams to ensure process reliability. A Bachelor's degree in a related engineering discipline is required. This position is on-site full-time.

Qualifications

• 7-10+ years of process engineering experience in an FDA-regulated or similarly controlled manufacturing environment.
• Strong troubleshooting capability in live production environments.
• Demonstrated SME-level knowledge and experience supporting Biological processes.

Responsibilities

• Provide process engineering support across production processes.
• Troubleshoot process and equipment issues directly with operators.
• Lead investigations and corrective actions tied to deviations.

Skills

Troubleshooting

Process Engineering

Biological Processes

Validation Lifecycle

Project Engineering

Education

Bachelor’s degree in Chemical, Mechanical, Industrial, or related Engineering

Tools

SAP

MES

Power BI

Job description

GMP Pros® in Omaha, NE is seeking a Process Engineer with 7-10+ years of experience in FDA-regulated environments. The role requires strong troubleshooting skills and expertise in biological processes, focusing on real-time support for manufacturing and packaging operations. Candidates are expected to provide hands-on engineering support, lead investigations, and collaborate with various teams to ensure process reliability. A Bachelor's degree in a related engineering discipline is required. This position is on-site full-time.