Principal MES Architect, CAR-T

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

Job Function:

Supply Chain Engineering

Job Sub Function:

Automation Engineering

Job Category:

People Leader

All Job Posting Locations:

US065 NJ Raritan - 700 Route 202 S, US121 NJ Raritan - 1000 Highway 202 S

Job Description:

About Innovative Medicine

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

We are searching for the best talent for Principal MES Architect, CAR-T to be in Raritan, NJ

Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR T platform and investigational treatment.

Are you interested in joining a team that is passionate about improving the lives of cancer patients?

This new position is part of the MAKE Supply Chain Systems Team and will work closely with the Site Lead of Supply Chain Systems and MES. The Principal MES Architect for Cell Therapy manufacturing will engage in collaboration with multi-functional teams and technology product lines, employing agile methodologies to implement NextGen Software solutions across automation systems deployed in Raritan. A robust technical background in Manufacturing Execution Systems (MES) and technology development is essential for this role.

Key Responsibilities

• MES Design & Implementation: Lead and perform the design, development, and deployment of (GxP) Electronic Manufacturing Batch Records (eMBR) enhancements within MES (Koerber PAS-X) for CAR-T processes, ensuring compliance with pharmaceutical industry standards and best practices.
• MES Configuration: Setup, configure, and maintain MES Master Data and Software Interfaces to meet operational requirements, ensuring robust integration with existing systems and processes.
• Application Development: Develop and deploy technical software applications that enhance the functionality of MES to improve monitoring, reporting, and data management for manufacturing.
• Technical Architecture: Provide MES architectural solutions and guidance for technology related projects, ensuring a fit-for-purpose enterprise architecture framework aligning with business goals.
• Multi-Functional Collaboration: Collaborate with local and global teams including MSAT, IT, Data, Operations, Quality to ensure MES solutions effectively support CAR-T manufacturing processes.
• Support Site MES Readiness: As necessary for FDA and Health Authority audits and inspections.

Qualifications

Education:

• A minimum of a Bachelor’s degree within Systems Engineering, Data Science, or a similar field.

Experience

Required:

• A minimum of 8-years of relevant professional experience (hands-on) with MES (Koerber PAS-X) within a regulated and multi-functional pharmaceutical manufacturing or software industry.
• In-depth practical and technical knowledge of MES (Koerber PAS-X), including software development lifecycle (SDLC) for GxP computer systems that support an operational manufacturing environment.
• Experience and the capability to maintain and enhance the MES ecosystem, including software interfaces and data flow connections with ERP, eLIMS, PIMS (OSI-PI), DCS, PLC/SCADA, and eCMMS.
• A demonstrated track record of leading and engaging in successful implementations of continuous improvement projects for MES and associated automation solutions that drive business excellence.
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