Sr Process Engineering - System Owner
Johnson & Johnson Innovative Medicine
Summary
The System Owner serves as the project manager and technical owner for assigned process systems and equipment packages from design through turnover to the end user. In this role, you will partner closely with design, construction, commissioning and qualification, manufacturing, quality, and external vendors to ensure systems are delivered safely, on schedule, within budget, and in alignment with GMP requirements. This position will own approximately $10 million to $20 million of process equipment packages and associated field-installed scope within the production building. Following turnover, the System Owner will continue to provide technical support during qualification batches, GMP readiness activities, and audit preparation.
Job description
Key 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.
Qualifications
Education: Bachelor's degree in Chemical Engineering, Mechanical Engineering, Bioprocess Engineering, or a related technical field. Master's degree, MBA; preferred.
Experience and Skills
Required:
- 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 manage multiple priorities and support multiple project activities simultaneously.
Preferred:
- Experience with large-scale monoclonal antibody production equipment, such as low-pressure liquid chromatography, inline conditioning or dilution, axial compression chromatography columns, solution preparation and storage, tangential flow filtration, washers, autoclaves, or clean-in-place systems.
- Experience working with external partners such as architecture and engineering firms, construction firms, and equipment vendors to develop, organize, and execute project plans.
- Startup, commissioning, qualification, or GMP readiness experience for a new or expanded manufacturing facility.
- Strong understanding of GMPs, regulatory expectations, business requirements, risk management, and project execution practices.
Other: Professional Engineer certification, or project management certification; preferred. Ability to travel up to 10%, including domestic and international travel.
Requirements
- Bachelor's degree in Chemical Engineering, Mechanical Engineering, Bioprocess Engineering, or a related technical field
- 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 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
Benefits
- Wellness programs
- Career development support
- Inclusive work environment
Company overview
Johnson & Johnson Innovative Medicine is the pharmaceutical division of Johnson & Johnson, leading the way in medical innovation with a relentless focus on bringing transformational treatments to patients worldwide. The company applies rigorous science and compassion to address the most complex diseases of our time, developing groundbreaking medicines across key therapeutic areas including oncology, immunology, neuroscience, and cardiopulmonary medicine. With deep expertise and global reach, Johnson & Johnson Innovative Medicine reimagines how devastating diseases are treated and cured, delivering hope and better care for millions of patients and their families. The organization pioneers the path from laboratory research to clinical application, championing patients every step of the way while maintaining an unwavering commitment to scientific excellence and patient-centered innovation.