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 hiring a Principal Engineer - Large Molecule Drug Substance

Description:

Support the deployment of the MTO aspiration “to innovate to safely supply quality products and services competitively, faster, always.” Responsible for providing advanced engineering design and start-up for GMP large molecule biologics manufacturing facility systems and equipment. Provide integrated equipment, utility, and facility engineering expertise with an operational focus in support of technology transfer and manufacturing projects to achieve ‘right first time’ execution and start-up. Drive innovative solutions in engineering support and process technology. Coordinate with the Technical Operations platform to ensure project alignment with technology standards and engineering specifications for manufacturing technology.

Key Responsibilities include, but are not limited to:

• Extensive interaction with external partners (A&E, construction firms, equipment vendors) to develop, organize, and execute project plans as SME and process systems owner. The incumbent should demonstrate the following: detail-oriented, goal-oriented, teamwork, customer focus, and a thorough understanding of GMPs and regulatory requirements.
• Serve as Process Engineering Expert to develop business-based technology solutions and provide integrated equipment, utility, and facility engineering expertise with an operational focus to support execution of strategic and key CAPEX manufacturing projects, driving ‘right first time’ start-up and execution.
• Provide strong technical leadership and expertise for technology transfers and new technology development projects to ensure processfit with plant methodology and practices.
• Explore and understand technology and manufacturing challenges and synthesize business needs, manufacturing requirements, engineering elements, technology inputs, etc. into business solutions.
• Provide technical leadership for multi-functional teams on various projects/process improvements and resolve inter-functional issues.
• High degree of collaboration with internal groups (manufacturing, quality, engineering) to develop standards and define project needs and priorities, as well as recruit project team members.
• The incumbent must also have a thorough understanding of business requirements, effective communication skills, leadership, interdependent partnering, and conflict and risk management skills.

Required Skills and Experience:

• Bachelor's Degree in Engineering, preferably chemical or mechanical.
• A minimum of three (3) years of process/plant engineering experience in GMP manufacturing of large molecule biologics facilities.
• Experience in greenfield or brownfield GMP manufacturing facility start-up, including process systems, automation, utilities, facilities, and operations.
• Strong technical background in process and manufacturing engineering, with strong analytical skills to synthesize business needs, manufacturing requirements, engineering elements, and technology inputs.