Senior Process System Owner
1 week ago
We are seeking a highly skilled Senior Process System Owner to join our team at J&J Family of Companies. As a key member of our Process Engineering team, you 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.
Requirements:
- 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.
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