Lead GMP Process Systems Engineer

jj; Charlotte (NC); On-site; USD 110,000 - 140,000; Full time

Job summary

Johnson & Johnson in North Carolina is seeking a System Owner for GMP process equipment packages in a biotherapeutics manufacturing facility. You will partner with design, construction, commissioning, and QA to ensure safe, on-time, and budget-aligned delivery.

You will own $10–$20 million of equipment, support qualification batches, GMP readiness, and audit prep, while leading cross-functional teams to achieve punch-list closure and smooth handover to end users.

Qualifications

• Minimum 5 years of process or plant engineering experience in commercial biologics manufacturing facilities.
• Experience in process engineering, plant engineering, equipment delivery, or manufacturing support within a GMP-regulated environment.
• Experience supporting the implementation of new equipment from construction through commissioning, qualification, and turnover.
• Demonstrated ability to lead or support cross-functional teams in a matrixed project environment.
• Strong communication, collaboration, problem-solving, and decision-making skills.
• Ability to manage multiple priorities and support multiple project activities simultaneously.

Responsibilities

• Lead system delivery: Provide engineering design and startup support for GMP biotherapeutics manufacturing facility systems and equipment.
• Drive right-first-time execution: Apply integrated equipment, utility, and facility engineering expertise with an operational focus to support successful startup.
• Manage equipment packages: Lead vendor equipment packages to ensure delivery on schedule, within budget, and in accordance with approved specifications.
• Support construction execution: Coordinate with the construction management team to resolve system clashes, address field issues, and maintain construction progress.
• Coordinate system readiness: Lead owner walkdowns, ensure punch list closure, and approve systems as ready for commissioning.
• Oversee commissioning and qualification: Review and approve commissioning and qualification protocols before and after execution.
• Resolve issues and manage change: Drive issue resolution during commissioning and create project change approval requests when needed.
• Ensure successful handover: Accountable for on-time commissioning completion, approval for GMP operation, and system handover to the end user.

Skills

Process engineering

GMP experience

Cross-functional teams

Project management

Communication skills

Prioritization

Education

Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Bioprocess Engineering

Master’s degree, MBA; preferred

Job description

Johnson & Johnson in North Carolina is seeking a System Owner for GMP process equipment packages in a biotherapeutics manufacturing facility. You will partner with design, construction, commissioning, and QA to ensure safe, on-time, and budget-aligned delivery.

You will own $10–$20 million of equipment, support qualification batches, GMP readiness, and audit prep, while leading cross-functional teams to achieve punch-list closure and smooth handover to end users.