Senior Engineer, Process System Owner

3 days ago

Raleigh, North Carolina, United States J&J Family of Companies Full time
Job Title: Senior Engineer, Process System Owner

Johnson & Johnson is seeking a Senior Engineer, Process System Owner to join our MAKE Asset Management Organization. The successful candidate will be responsible for providing advanced engineering design and start-up of GMP large molecule biologics manufacturing facilities, systems, and equipment.

Key Responsibilities:
  • Drive the end-to-end delivery of equipment and process packages, from concept to handover to end users.
  • Be the main point of contact and key interface throughout the project, for all equipment vendors in their scope.
  • Assist in the management of process engineering supply chain project plans, key milestones and objectives.
  • Deliver front-line solutions for Process Engineering non-conformance, subsequent corrective, and preventive actions.
  • Ensure in a timely manner, escalation of any Process Engineering issues or concerns to the next management level.
  • Coach more junior colleagues in techniques, processes, and responsibilities.
  • Support the development of integrated business solutions for new technology strategies and introduction into manufacturing, site analysis, and strategic manufacturing projects.
  • Support 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'.
  • Leverage internal and external expertise and apply principles of knowledge.
  • Drive 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:
  • 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 Qualifications:
  • 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.

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