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. + Deep knowledge of applying ISA standards, FDA GxP, 21 CFR Part 11, EU Annex 11, ISPE GAMP-5 to MES development and implementations within pharmaceutical or biotechnology manufacturing. + Excellent interpersonal skills (written, verbal, and presentation). Must have the ability to influence and make data-driven decisions based on technical expertise and according to the J&J Credo. **Preferred** + Experience with analysis of computer system data to support manufacturing process optimization. + Competence in developing and supporting long-term technology roadmaps and strategic directives. + Familiarity with Cell Therapy Chain of Custody (COC) and Chain of Identity (COI) systems. **Other** + This position will be based at the Johnson & Johnson Site: 1000 US 202 S, Raritan, NJ 08869. + This position is required to be on site in Raritan 3-days per week and requires up to 5% domestic and international travel, based on business meeting needs. Why Join Us? This role presents a unique opportunity to lead transformative initiatives in Cell Therapy Supply Chain Systems and Automation, promoting standard processes in technology solutions management and supporting business objectives. If you're a visionary leader passionate about operational excellence and continuous improvement, we invite you to be part of our transformative journey. This position is a great opportunity for high-potential talent looking for accelerated development and providing hope to cancer patients. 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 and 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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is: $100,000 to $172,500 **The anticipated base pay range for this position is :** The anticipated base pay range for this position is: $100,000 to $172,500 Additional Description for Pay Transparency: The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. · • 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)). • This position is eligible to participate in the Company’s long-term incentive program. • 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 of Work, Personal and Family Time - up to 40 hours per calendar year • Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.