Senior Process Engineer

Mason-Grey Corporation is hiring a Senior Process Engineer to establish and optimize manufacturing operations for our Large Molecule Drug Substance (LMDS) biologics facility in Wilson, Wilson County. This is a full-time, on-site position for an experienced engineer ready to shape the operational foundation of a state-of-the-art biologics manufacturing site.

About the Role

As Senior Process Engineer, you'll lead the engineering, design, and commissioning of our advanced LMDS biologics manufacturing facility. You'll bridge process development with large-scale production, ensuring regulatory compliance, operational excellence, and timely facility startup. This role demands expertise in GMP biologics manufacturing, the ability to manage complex technology transfer initiatives, and experience executing substantial capital projects in a regulated environment.

What You'll Do

• Direct process engineering activities from design phase through facility startup and initial production
• Oversee technology transfer from development to manufacturing scale
• Manage engineering design, equipment selection, and systems integration for biologics production
• Ensure compliance with GMP, FDA, and other applicable regulatory standards
• Lead cross-functional teams through facility commissioning and operational readiness
• Develop and implement process control strategies and manufacturing procedures
• Identify process improvements and drive continuous operational optimization

What We're Looking For

• Deep, hands-on experience in GMP biologics manufacturing or biotech process engineering
• Demonstrated success managing large capital projects and facility construction or startup
• Strong knowledge of process engineering principles, scale-up methodology, and technology transfer
• Expertise in LMDS (monoclonal antibodies, recombinant proteins, or similar) manufacturing preferred
• Solid understanding of regulatory requirements for biologics manufacturing (FDA, EMA guidance)
• Excellent project management, leadership, and cross-functional collaboration skills
• Bachelor's degree in Chemical Engineering, Bioprocess Engineering, or related discipline (or equivalent experience)

About Mason-Grey Corporation

Mason-Grey Corporation advances large-scale biologics manufacturing with cutting-edge facility design and operational expertise. We're committed to delivering reliable, compliant, high-quality biologics production to support critical healthcare innovation.

How to Apply

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.