Senior GMP Process Systems Owner & Project Lead

6046-JANSSEN SUPPLY GROUP, LLC. Legal Entity; 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 design, startup and handover for GMP Biotherapeutics facility systems. You will manage supplier packages, coordinate with construction, and ensure readiness for commissioning and GMP approval while partnering with design, manufacturing, quality, and external vendors.

The role requires 5+ years in process/plant engineering within a GMP environment, strong leadership, and the ability to travel up to 10%

Qualifications

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Bioprocess Engineering, or related field.
• 5+ years of process or plant engineering experience in commercial biologics manufacturing facilities.
• Experience leading cross-functional teams in a GMP-regulated environment.

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

Analytical Reasoning

Problem Solving

Project Management

Analytical Reasoning

Computerized Equipment Skills

Emerging Technologies

Gemba Kaizen

Issue Escalation

Lean Supply Chain Management

Process Control

Process Oriented

Product Improvements

Science

Technology

Engineering, and Math (STEM) Applicat

Situational Awareness

Supply Planning

Technical Research

Technologically Savvy

Validation Testing

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 design, startup and handover for GMP Biotherapeutics facility systems. You will manage supplier packages, coordinate with construction, and ensure readiness for commissioning and GMP approval while partnering with design, manufacturing, quality, and external vendors.

The role requires 5+ years in process/plant engineering within a GMP environment, strong leadership, and the ability to travel up to 10%