Process Engineer, GMP Biologics & Tech Transfer

Katalyst CRO; Wilson (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking an experienced Process Engineer to lead design and startup of GMP large molecule biologics facility systems in the US. You will coordinate with operations to ensure right-first-time execution and start-up of integrated equipment, utilities, and facilities engineering.

The role emphasizes collaboration, technical leadership, and delivering scalable manufacturing solutions across technology transfer programs.

Qualifications

• Bachelor's or equivalent in Chemical or Mechanical Engineering.
• 8+ years of process/plant engineering experience in GMP MFG large molecule biologics facilities.
• Experience in green or brown field GMP MFG facility start-up including process systems, automation, utilities, facilities and operations.
• Strong technical background in Process and Manufacturing engineering.

Responsibilities

• Extensive interaction with external partners to develop, organize and execute project plans as SME and process systems owner.
• Serve as Process Engineering Expert to develop technology solutions and provide integrated equipment, utility, and facility engineering expertise.
• Provide strong technical leadership and expertise for technology transfers and new technology development projects.
• Explore and understand manufacturing challenges and synthesize business needs into business solutions.
• Provide technical leadership of multi-functional teams on projects and resolve inter-functional issues.
• Collaborate with manufacturing, quality, engineering to develop standards and priorities; recruit project team members.

Skills

Process engineering

GMP manufacturing

Regulatory compliance

Project management

Cross-functional collaboration

Technical leadership

Education

Bachelor's degree in Chemical or Mechanical Engineering

MS/MBA/Ph.D. PE Certificate preferred

Job description

Katalyst CRO is seeking an experienced Process Engineer to lead design and startup of GMP large molecule biologics facility systems in the US. You will coordinate with operations to ensure right-first-time execution and start-up of integrated equipment, utilities, and facilities engineering.

The role emphasizes collaboration, technical leadership, and delivering scalable manufacturing solutions across technology transfer programs.