Lead Process Engineer - Large Molecule Drug Substance

Kelly; Wilson (NC); On-site; USD 140,000 - 210,000; Full time

Job summary

Kelly, in partnership with Johnson & Johnson, is seeking a Principal Engineer for Large Molecule Drug Substance to lead GMP engineering for a biologics facility. The role focuses on process systems ownership, equipment, utilities, and start-up, with strong emphasis on technology transfer and regulatory compliance.

The successful candidate will collaborate with external partners and internal teams to drive right-first-time execution, support CAPEX projects, and deliver innovative engineering

Qualifications

• Bachelor's degree in Engineering required; chemical or mechanical preferred.
• 3+ years of process/plant engineering experience in GMP manufacturing of large molecule biologics facilities.
• Experience in greenfield or brownfield GMP facility start-up, including process systems, automation, utilities, facilities, and operations.
• Strong analytical skills to synthesize business needs, manufacturing requirements, engineering elements, and technology inputs.

Responsibilities

• Interact with external partners (A&E, construction firms, equipment vendors) to develop, organize, and execute project plans as SME and process systems owner.
• Serve as Process Engineering Expert to develop tech solutions and provide integrated equipment, utility, and facility engineering expertise for CAPEX projects.
• Provide technical leadership for technology transfers and new technology development to ensure process fit with plant methodology.
• Explore manufacturing challenges and translate them into business solutions.
• Lead multi-functional teams on projects/process improvements and resolve inter-functional issues.
• Collaborate with internal groups to develop standards, define project needs and priorities, and recruit project team members.
• Demonstrate a thorough understanding of business requirements, effective communication, leadership, partnering, and risk management.

Skills

Process engineering

GMP manufacturing

Regulatory compliance

Cross-functional teamwork

Education

Bachelor's degree in Engineering

Job description

Kelly, in partnership with Johnson & Johnson, is seeking a Principal Engineer for Large Molecule Drug Substance to lead GMP engineering for a biologics facility. The role focuses on process systems ownership, equipment, utilities, and start-up, with strong emphasis on technology transfer and regulatory compliance.

The successful candidate will collaborate with external partners and internal teams to drive right-first-time execution, support CAPEX projects, and deliver innovative engineering