Senior Engineer, Process System Owner

Senior Engineer, Process System Owner – 2406200744W

Description

Johnson & Johnson is currently seeking a(n) Senior Engineer, Process System Owner to join our MAKE Asset Management Organization out of our new Large Molecule Drug Substance Site located in Wilson, NC .

While this role will ultimately support the site operations located in Wilson NC, this role will also be required to support the project phase across both design & construction. For the project design phase, the role will require you to be present with our design teams in the Greater Philadelphia region. Once the design phase is completed, this role will support the construction and operational start-up of the site. For this, you will be required to be on site in Wilson, NC. Based on your current location the hiring team will work with you to determine travel and relocation arrangements. In steady state, we expect travel to be less than 10%.

J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J’s significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations.

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 https://www.jnj.com/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential.

At Johnson & Johnson, we all belong.

The MAM (MAKE Asset Management) organization operates as one integrated team in the delivery of Engineering, Maintenance and Execution Systems solutions. We operate in a standard, coordinated and consistent manner in support of the current and future requirements of our Manufacturing and Manufacturing Science and Technology (MSAT) and in partnership with key internal/external network.

The Senior Engineer, Process System Owner will be responsible for providing advanced engineering design and start-up of GMP large molecule biologics manufacturing facilities, systems, and equipment. The incumbent will also be providing engineering and technical/business support for new complex production technologies, processing equipment, and production network analysis. Provide integrated equipment, utility, and facility engineering expertise with an operational focus in support of technology transfer and manufacturing projects to support ‘right first time’ execution and start up.

Key Responsibilities:

Drive the end-to-end delivery of equipment and process packages, from concept to handover to end users; i.e. provide technical leadership to the design, construction, commissioning and qualification of all equipment in their scope.

Be the main point of contact and key interface throughout the project, for all equipment vendors in their scope; to lead the resolution of technical issues and ensure all packages are delivered to the end user on time and to budget.

Assists in the management of process engineering supply chain project plans, key milestones and objectives, to ensure engineering outputs meet customer’s operational needs and requirements.

Delivers front-line solutions for Process Engineering non-conformance, subsequent corrective, and preventive actions, by documenting, investigating, and conducting root cause analysis, and successfully implementing corrective actions.

Ensures in a timely manner, escalation of any Process Engineering issues or concerns to the next management level.

Coaches more junior colleagues in techniques, processes, and responsibilities.​

Supports the development of integrated business solutions for new technology strategies and introduction into manufacturing, site analysis, and strategic manufacturing projects.

Supports the development and deployment of process fit to plant methodology that ensures all aspects of the manufacturing process technical transfer are comprehensively and consistently ‘done right’.

Leverages internal and external expertise and applies principles of knowledge.

Drives innovative solutions in engineering support, and process technology.

Partner with MSAT (Manufacturing, Science and Technology), GET (Global Engineering & Technology) and E&PS (Engineering and Property Services) to ensure project alignment with technology standards and engineering specifications for manufacturing technology.

Interaction with external partners (A&E, construction firms, equipment vendors) to develop, organize and execute project plans as Subject Matter Expert and Systems Owner.

Serve as Process Engineering Expert to develop business-based technology solutions and provide integrated equipment, utility, and facility engineering expertise with an operational focus to support execution of strategic and key CAPEX manufacturing projects, driving ‘right first time’ start up and execution.

Explore and understand technology and manufacturing challenges and synthesize business needs, manufacturing requirements, engineering elements, and technology inputs, etc. into business solutions.

Provide technical leadership of multi-functional teams on projects/ process improvements.

High degree of collaboration with internal (manufacturing, quality, engineering) to develop standards and define project needs and priorities as well as recruiting project team members.

Qualifications

Required:

BS. Degree in Engineering, Science, or related discipline.

A minimum of 4 years of process engineering experience in a manufacturing biopharmaceutical environment.

Strong technical background in process and manufacturing engineering, with analytical skills to synthesize business needs, manufacturing requirements, engineering elements, and technology inputs into business solutions.

Strong working knowledge of bio/pharmaceutical processes, utilities, and facilities.

In-depth knowledge of cGMPs for Maintenance in an FDA-regulated environment.

Project management experience, with the ability to lead and/or support multiple projects simultaneously.

Engineer and modify processes to ensure right-first-time process startup.

Detail- and goal-oriented, with a customer focus and thorough understanding of GMPs and regulatory requirements.

Strong influencing, partnering, collaboration, conflict and risk management, critical thinking, and excellent oral/written presentation skills.

Preferred:

Experience in greenfield or brownfield GMP manufacturing facility start-up, including process systems, automation, utilities, facilities, and operations.

MS/MBA/Ph.D.

Professional Engineer Certificate.

Knowledge of Manufacturing Equipment Excellence (ME2) and best practices for maintenance and reliability.

FPX certification and/or Six Sigma and/or Lean experience.

This job posting is anticipated to close on 10/20/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

Vacation – up to 120 hours per calendar year

Sick time – up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year

Holiday pay, including Floating Holidays – up to 13 days per calendar year

Work, Personal and Family Time – up to 40 hours per calendar year

Additional information can be found through the link below.

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

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 .

Primary Location NA-US-North Carolina-Wilson

Other Locations NA-US-North Carolina-Raleigh, NA-US-North Carolina-Goldsboro, NA-US-Pennsylvania-Horsham, NA-US-Pennsylvania-Spring House, NA-US-North Carolina-Greenville, NA-US-North Carolina-Rocky Mount

Organization Janssen Biotech, Inc. (6014)

Relocation Eligible: Yes – Within Country

Job Function Process Engineering

Req ID: 2406200744W