Lead Process Engineer - Biologics GMP Start-up

Katalyst CRO; Wilson (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

Katalyst CRO is seeking a dedicated Process Engineer to lead design and startup activities for GMP large molecule biologics facilities in Wilson, NC. The role focuses on integrated equipment, utilities, and overall manufacturing project execution to ensure right-first-time startup.

Responsibilities include partnering with external vendors, driving technology transfers, and guiding multi-functional teams to meet manufacturing standards and project milestones.

Qualifications

• Bachelor's degree in Chemical or Mechanical Engineering required.
• Minimum 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 with ability to synthesize business needs and technology inputs.

Responsibilities

• Extensive interaction with external partners (A&E, construction firms, equipment vendors) 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 technical leadership for technology transfers and new technology development projects to ensure fit to plant methodology and practices.
• Explore and understand challenges and translate manufacturing needs into business solutions.
• Provide technical leadership of multi-functional teams on projects and process improvements; resolve inter-functional issues.
• Collaborate with internal manufacturing, quality, and engineering to define standards and priorities; assist in recruiting project team members.

Skills

Process engineering

Manufacturing engineering

Analytical skills

GMP knowledge

Education

Bachelor's or equivalent University Degree in Chemical or Mechanical Engineering

MS/MBA/Ph.D. PE Certificate

Job description

Katalyst CRO is seeking a dedicated Process Engineer to lead design and startup activities for GMP large molecule biologics facilities in Wilson, NC. The role focuses on integrated equipment, utilities, and overall manufacturing project execution to ensure right-first-time startup.

Responsibilities include partnering with external vendors, driving technology transfers, and guiding multi-functional teams to meet manufacturing standards and project milestones.