Process Engineer - Biologics

Position Summary

Seeking an experienced Process Engineer to support the design, installation, commissioning, qualification, and startup of a large-scale biologics drug substance manufacturing facility. The role will support GMP process systems, technology transfer, CAPEX projects, and operational readiness.

Key Responsibilities

• Support process equipment and systems from design through startup and operational handover.
• Troubleshoot equipment and process issues and implement engineering improvements.
• Serve as a technical resource for GMP biologics manufacturing systems.
• Support technology transfer, process-fit-to-plant assessments, and CAPEX execution.
• Coordinate with Manufacturing, Quality, Automation, Validation, Engineering, construction teams, and vendors.
• Ensure compliance with GMP, safety, quality, and project requirements.

Required Qualifications

• Bachelor’s degree in Chemical, Mechanical, Biochemical Engineering, or a related discipline.
• 8+ years of process or plant engineering experience in GMP large molecule biologics manufacturing.
• Experience with greenfield or brownfield facility startup, commissioning, and qualification.
• Strong knowledge of biologics drug substance processes, equipment, utilities, and automation.
• Strong troubleshooting, project coordination, communication, and leadership skills.
• Legally authorized to work in the United States and available to work onsite in Wilson, NC.

Preferred: Technology transfer, CAPEX, Lean/Six Sigma, advanced degree, or PE certification.

US-based travelers and candidates willing to relocate will be considered.