CAR-T Manufacturing Systems Senior Engineer
Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a CAR-T Manufacturing Systems Senior Engineer!
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Biotech, Inc. is part of the Janssen Pharmaceutical Companies.
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? We work on the most sophisticated treatment options available today. To support the global CAR-T program, Janssen is rapidly growing its manufacturing and laboratory capabilities. This position offers a perfect environment to understand CAR-T Cell Processing Manufacturing Operations and the underlying Supply Chain systems (Planning, Quality, Distribution, EHS, etc.), something unique given the limited amount of Cell Therapy manufacturers worldwide. Apply today for this exciting chance to be part of the #CAR-T team!
Our Raritan, NJ Cell Therapy facility is scaling up operational flows to serve more patients and meet the highest quality standards without compromising manufacturing efficiency. This exciting new role works with the CAR-T Supply Chain Systems Lead and will be tasked with the expansion of current system capabilities and will be tasked with the design, plan, and implementation of multiple electronic Batch Records with the goal to become a paper-less manufacturing facility.
The Senior Engineer should be passionate about Data and will work together with Janssen´s Data Lake team to acquire business insights and propose data-driven solutions. All Batch Record modelling will be done in the latest PAS-X MES software (v3.3); any prior experience will be preferred, though basic training will be available for a candidate who shows strong willingness to master this critical manufacturing software tool. This is an outstanding opportunity to sit on an E2E Supply Chain team and develop critical thinking & business experience. A fantastic role for a high potential talent seeking accelerated development.
- Collaborate closely with JJT, Manufacturing Ops, Manufacturing Excellence, MSAT, Quality, partners at Legend Biotech, and cross-functional teams through the projects' execution to ensure seamless delivery of cell therapy Manufacturing Execution Systems (MES)
- Define Base Design for Master Batch Records and Recipe Structure in the MES system, supporting the process evolution to meet the expansion requirements
- Creation of Master Batch Records including MBR Modelling
- Participate in compliance inspections for topics related to manufacturing systems
- Coordinate UAT Definition and Execution for Computer System Validation (CSV), and lead Integration testing (IQ) and Functional testing (OQ)
- Build, review, and manage site specific Work Instructions and execute against global SOPs (including back up, disaster recovery, user administration etc.)
- Provide (User) training to end users (Operations and Operations Support)
- Support System Integration (SAP, eLIMS, Data Lake, OSI PI, etc.)
- Serve as SME to support various projects/initiatives requiring Manufacturing data
- Minimum of a Bachelor’s or equivalent University Degree required; focused degree in Engineering, Information Technology, Industrial Automation, or related field preferred
Experience and Skills:
- Minimum 4 years of relevant work experience
- Experience with supply chain systems SAP, eLIMS, and PAS-X MES (or equivalent systems)
- Experience with Manufacturing Processes (GxP) and related Master Data Management
- High affinity for New Technologies and Processes
- Excellent written and verbal communication skills including experience writing procedures for a technical environment, documenting complex technical solutions, and communicate effectively with internal and external partners
- Working knowledge of one or more of the following automation systems/technologies: PLC, DeltaV Distributed Control System, OSI PI Historian, PLC/SCADA, CMMS systems, OMP, Anaplan, and/or Tableau
- Working knowledge of Computer System Validation (CSV) and related data integrity standards
- Familiar with Chain of Custody and/or Chain of Identity systems
- Experience in actively participating in FDA or other Health Authority inspections
- Experience within the Pharmaceutical industry
- Experience working in a large, highly-matrixed environment
- Project Management certification
- Requires up to 10% domestic and/or international travel
The anticipated base pay range for this position is $73,000 to $117,300.
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 .