Exp Engineer- Process Engineering System Owner

Posted 5 Days Ago
Be an Early Applicant
Wilson, NC, USA
In-Office
Senior level
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
Owns process systems and equipment packages for GMP biologics manufacturing facilities from design through turnover. Leads vendor coordination, construction support, commissioning, qualification, punch-list closure, issue resolution, change control, and GMP readiness. Partners with engineering, construction, manufacturing, quality, vendors, and other cross-functional teams to deliver systems safely, on schedule, within budget, and in compliance with approved specifications and regulatory requirements.
Summary Generated by Built In

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at jnj.com.

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 https://www.jnj.com/innovative-medicine

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 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 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:

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

Skills Required

  • Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Bioprocess Engineering, or a related technical field
  • At least 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 implementing new equipment from construction through commissioning, qualification, and 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 project activities simultaneously
  • Master’s degree or MBA
  • Experience with large-scale monoclonal antibody production equipment
  • Experience working with architecture and engineering firms, construction firms, and equipment vendors
  • Startup, commissioning, qualification, or GMP readiness experience for a new or expanded manufacturing facility
  • Understanding of GMPs, regulatory expectations, business requirements, risk management, and project execution practices
  • Professional Engineer certification or project management certification

Johnson & Johnson Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.

  • Healthcare Strength Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
  • Retirement Support Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
  • Parental & Family Support Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.

Johnson & Johnson Insights

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The Company
HQ: New Brunswick, NJ
143,612 Employees
Year Founded: 1886

What We Do

Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines

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