Senior Process Engineering System Owner (GMP)

Biopharma Careers; Kansas; On-site; USD 110,000 - 160,000; Full time

Job summary

Johnson & Johnson is seeking a System Owner for assigned process systems and equipment packages from design through turnover to the end user. You will partner with design, construction, commissioning, qualification, manufacturing, quality, and external vendors to ensure safe, on-time delivery within budget and GMP alignment.

This role owns multi-million dollar packages, drives commissioning and qualification, supports turnover and GMP readiness, and ensures a smooth handover to end users while

Qualifications

• Minimum 5 years of process or plant engineering experience in commercial biologics manufacturing facilities.
• Experience in process/plant engineering, equipment delivery, or manufacturing support within GMP environment.
• Experience leading cross-functional teams in a matrixed project environment.
• Strong communication, collaboration, problem-solving and decision-making skills.
• Able to manage multiple priorities and project activities.

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 compliance

Cross-functional teamwork

Project management

Communication skills

Problem-solving

Education

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

Master’s degree or MBA; preferred

Job description

Johnson & Johnson is seeking a System Owner for assigned process systems and equipment packages from design through turnover to the end user. You will partner with design, construction, commissioning, qualification, manufacturing, quality, and external vendors to ensure safe, on-time delivery within budget and GMP alignment.

This role owns multi-million dollar packages, drives commissioning and qualification, supports turnover and GMP readiness, and ensures a smooth handover to end users while