GMP Process Systems Owner — Biologics Manufacturing

Johnson Johnson; Wilson (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

Johnson & Johnson in the United States seeks a System Owner for GMP biotherapeutics process systems. You will manage design through turnover, partnering with design, construction, commissioning, manufacturing, quality, and external vendors to ensure systems are delivered safely, on schedule, and in alignment with GMP requirements.

The position will own approximately $10–$20 million of process equipment packages and provide ongoing support during qualification batches, GMP readiness activities,

Qualifications

• Minimum 5 years of process or plant engineering in commercial biologics facilities.
• Experience in GMP-regulated environments.
• Experience delivering equipment from construction through commissioning, qualification, turnover.
• 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

Cross-functional teams

Communication

Problem solving

Decision making

Multitasking

Education

Bachelor's in Chemical/Mechanical Eng

Master's degree preferred

Job description

Johnson & Johnson in the United States seeks a System Owner for GMP biotherapeutics process systems. You will manage design through turnover, partnering with design, construction, commissioning, manufacturing, quality, and external vendors to ensure systems are delivered safely, on schedule, and in alignment with GMP requirements.

The position will own approximately $10–$20 million of process equipment packages and provide ongoing support during qualification batches, GMP readiness activities,