Senior Process Engineer & System Owner - GMP Biotech

Johnson & Johnson Co.; Wilson (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

Johnson & Johnson in Wilson, North Carolina, is seeking a System Owner to lead GMP biotherapeutics process systems from design through turnover. You will partner with design, construction, qualification, manufacturing, quality, and external vendors to ensure safe, on-time delivery within GMP guidelines.

The role requires a minimum of 6 years in process or plant engineering in biologics, with strong leadership and communication skills. Travel up to 10% may be required as projects evolve.

Qualifications

• A minimum 6 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 travel up to 10%.

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

Agile Decision Making

AI Judgement Integration

Coaching

CAPA

Critical Thinking

Emerging Technologies

Issue Escalation

Lean Supply Chain

Problem Solving

Process Control

Process Engineering

Product Costing

Product Improvements

Science

Technology

Engineering

STEM Application

Education

Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Bioprocess Engineering, or a related technical field

Master’s degree, MBA; preferred

Job description

Johnson & Johnson in Wilson, North Carolina, is seeking a System Owner to lead GMP biotherapeutics process systems from design through turnover. You will partner with design, construction, qualification, manufacturing, quality, and external vendors to ensure safe, on-time delivery within GMP guidelines.

The role requires a minimum of 6 years in process or plant engineering in biologics, with strong leadership and communication skills. Travel up to 10% may be required as projects evolve.