GMP Biologics Process Engineer — Tech Transfer Lead

Katalyst CRO; Huntsville (AL); On-site; USD 120,000 - 160,000; Full time

Job summary

Katalyst CRO seeks a senior Process Engineer to support the deployment and startup of GMP large molecule biologics facility systems, equipment, and utilities. The role emphasizes right-first-time execution, technology transfer, and collaboration across Technical Operations to meet manufacturing standards.

The incumbent will lead cross-functional teams, drive innovative engineering solutions, and ensure alignment with project objectives and regulatory requirements.

Qualifications

• Bachelor's degree in Chemical or Mechanical Engineering (or equivalent).
• Eight years of process/plant engineering experience in GMP manufacturing.
• Experience in GMP large molecule biologics facilities and start-up projects.
• PE certificate preferred.

Responsibilities

• Coordinate with external partners and internal teams to develop and execute project plans as SME and process systems owner.
• Serve as Process Engineering Expert to develop integrated equipment, utility, and facility engineering solutions for technology transfer and startup.
• Provide technical leadership for technology transfers and new technology development to ensure process fit to plant methodology.
• Lead multi-functional teams on projects and resolve inter-functional issues.
• Collaborate with manufacturing, quality, and engineering to define standards and priorities, and assist in recruiting project members.
• Demonstrate strong communication, leadership, and risk management across the organization.

Education

Bachelor's degree in Chemical or Mechanical Engineering

MS/MBA/Ph.D. with PE certificate preferred

Job description

Katalyst CRO seeks a senior Process Engineer to support the deployment and startup of GMP large molecule biologics facility systems, equipment, and utilities. The role emphasizes right-first-time execution, technology transfer, and collaboration across Technical Operations to meet manufacturing standards.

The incumbent will lead cross-functional teams, drive innovative engineering solutions, and ensure alignment with project objectives and regulatory requirements.