Senior Process Engineer - Large Molecule Drug Substance

Kelly; Wilson (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

Kelly, in partnership with Johnson & Johnson, seeks a Senior Principal Engineer - Large Molecule Drug Substance to drive engineering design and start-up for GMP biologics facilities. You will lead process systems ownership, integrate equipment, utilities, and facilities engineering, and support technology transfers with a focus on right first time execution.

You will collaborate with internal and external partners to ensure engineering standards, regulatory compliance, and project alignment with

Qualifications

• Bachelor's Degree in Engineering, preferably chemical or mechanical.
• 8+ 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.

Responsibilities

• Interact with external partners (A&E, construction firms, equipment vendors) as SME and process systems owner.
• Provide integrated equipment, utility, and facility engineering expertise to support CAPEX projects and start-up.
• Lead technology transfer and new technology development to align with plant methodology and practices.
• Collaborate with manufacturing, quality, and engineering to develop standards and set project priorities.
• Recruit project team members and manage cross-functional teams for process improvements.
• Communicate effectively to manage risks and align with business requirements.

Skills

Process engineering

GMP compliance

Technology transfer

Project leadership

Cross-functional collaboration

Analytical skills

Education

Bachelor's degree in Engineering

Job description

Kelly, in partnership with Johnson & Johnson, is hiring a Senior 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 process
• fit 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 eight (8) 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.