Learn more and apply to this exciting new role!
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.
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
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]
If you are under 18 years of age, you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
Required Skills
Preferred Skills
Agile Decision Making, AI Judgement Integration, Coaching, Corrective and Preventive Action (CAPA), Critical Thinking, Emerging Technologies, Issue Escalation, Lean Supply Chain Management, Problem Solving, Process Control, Process Engineering, Product Costing, Product Improvements, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Technical Research, Technologically Savvy, Validation Testing, Vendor Selection
