Exp Engineer- Process Engineering System Owner

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Wilson North Carolina United States of America

Job Description:

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at 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 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:

• Bachelors degree in Chemical Engineering Mechanical Engineering Bioprocess Engineering or a related technical field.

• Masters degree MBA; preferred

Experience and Skills:

Required:

• A minimum 5 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 .

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 parents 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 internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Analytical Reasoning Computerized Equipment Skills Emerging Technologies Gemba Kaizen Issue Escalation Lean Supply Chain Management Problem Solving Process Control Process Engineering Process Oriented Product Improvements Science Technology Engineering and Math (STEM) Application Situational Awareness Supply Planning Technical Research Technologically Savvy Validation Testing

Required Experience:

IC