Process Engineer

About the Role

Our client is seeking an experienced Process Engineer Subject Matter Expert (SME) to support the installation, startup, commissioning, and operational readiness of a new GMP biotechnology manufacturing facility. The SME will serve as the technical expert for buffer and media preparation systems, including process tanks and associated equipment.

This individual will work closely with Construction, Equipment Vendors, Project Engineering, CQV, and Operations to ensure successful equipment installation, startup, troubleshooting, turnover, and operational readiness.

Responsibilities

• Serve as the technical SME for buffer and media preparation systems, including process tanks and associated equipment.
• Support construction quality activities by coordinating with equipment vendors, construction management, and project engineering teams during equipment installation.
• Oversee equipment installation to ensure systems are installed in accordance with design specifications and project requirements.
• Support equipment startup, commissioning, and operational readiness activities.
• Troubleshoot process equipment issues during startup and provide technical resolution when issues extend beyond CQV activities.
• Interface with vendors, engineering, CQV, and operations to resolve technical challenges and ensure successful equipment turnover.
• Review engineering documentation, equipment packages, and technical deliverables throughout the project lifecycle.
• Ensure all activities are executed in accordance with GMP and site engineering standards.

Requirements

• Strong hands-on experience with buffer and media preparation systems in a GMP biotechnology or pharmaceutical manufacturing environment.
• Technical expertise with process tanks and associated process equipment.
• Experience supporting equipment installation, startup, commissioning, and operational readiness.
• Ability to troubleshoot and resolve technical issues during equipment startup.
• Experience working cross-functionally with Construction, Engineering, CQV, Operations, and Equipment Vendors.
• Strong understanding of GMP requirements and site engineering standards.
• Experience reviewing engineering documentation, equipment packages, and technical deliverables.
• Strong communication and technical problem-solving skills.

Location: Wilson, NC
Duration: 6+ Months