Principal Cell Therapy Engineer

Principal Cell Therapy Engineer 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. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver breakthroughs tomorrow, profoundly impacting health for humanity. Locations: Horsham, Pennsylvania; Raritan, New Jersey; Spring House, Pennsylvania. Job Function: Supply Chain Engineering Job Sub Function: Process Engineering Job Category: Scientific/Technology Job Description We are searching for the best talent for a Principal – Cell Therapy Engineer to join our team CAR‑T is an innovative treatment that uses the power of the patient’s own immune system. A patient’s T‑cells are genetically modified to eliminate cancer cells. This groundbreaking technology offers hope for patients where other therapies have failed. Janssen Biotech is developing, manufacturing, and commercializing products in the CAR‑T space. The Cell Therapy Senior Principal Engineer is part of the Operations workstream and closely connected to the Quality and Tech Transfer workstream. You will act as a decision maker in the Operations workstream, shaping the manufacturability of the R&D process, collaborating on the development and set‑up of supply chain technology and processes for a new facility design, and supporting the successful transfer of the CAR‑T process, the timely start of clinical and commercial manufacturing, and further improvement and scale‑up of the process. Key Responsibilities Provide operational expertise in Technical Operations discussions based on GMP knowledge of facility design, aseptic techniques, and process development for ATMPs or equivalent industry transferable to cell and gene therapy products. Provide operational expertise in the R&D process to support reliable, repeatable, GMP manufacturability of the process in development. Provide operational guidance to the facility resource model, shaping product development and operational processes for cost‑competitiveness. Lead the development of user requirements for new technology and processes, translating requirements into operational performance efficiencies and impacts. Ensure completion of user acceptance testing to deliver user requirements and performance efficiencies. Find opportunities for improvement and lead their development and implementation. Immerse yourself in CAR‑T processes, building proven expertise, ensuring timely development and implementation of robust operational documentation frameworks (operating procedures, work instructions, batch records, etc.), and ensuring adequate training of the organization. Ensure end‑to‑end overview of the flow of all material required in your area, including process material, documents, waste, and samples. Identify risks and opportunities in relation to process contamination, cross‑contamination, and mix‑up control on the shop floor and drive follow‑up initiatives for improvement in close cooperation with operators, QA, QC, and operations management. Act as a lead in root‑cause analysis related to safety/quality issues in your area. Act as a spokesperson for your area during health‑care inspections. Support the lean design and implementation of Information Technology systems (SAP, MES, etc.) including future releases to continuously improve performance and compliance. Represent Operations in Process Design and Process Qualification. Instill an approach of high standards of safety and cGMP compliance, ensuring the reliability of your operations and readiness for audits or inspections at all times. Develop an appropriate governance structure to monitor the operational performance of your area at acceptance testing, startup, and ongoing. Additional Responsibilities – CAR‑T Production System Focus Develop and maintain in‑depth understanding of manufacturing processes (incl. scientific understanding), operational procedures, and manufacturing environment (facilities, utilities, equipment, systems, processes). Develop and maintain robust understanding of aseptic and cell processing techniques. Develop and maintain understanding of relevant regulatory frameworks (general GMP and specific focus on ATMP). Understand biosafety. Qualifications Education Minimum of a Bachelor’s or equivalent University Degree. Advanced degree or focused degree preferred in Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry, or related field. Required Experience and Skills Minimum 6 years of relevant work experience. Experience in one or more of the following areas: cGMP manufacturing, operations technology development, tech transfer, process and equipment validation, and/or quality management. Demonstrated ability to collaborate internally and externally within a matrix environment. Patient‑centered mindset. Commitment to diversity, equity, and inclusion. Experience and/or knowledge of GMP shop floor manufacturing processes. Proactive, start‑up attitude and solution‑oriented mindset. Strong prioritization skills to provide clear instructions to peers. Experience working in a rapidly changing environment and acting as a change agent. Strong verbal and written communication skills with ability to influence without authority. Ability to work independently, prioritizing and managing multiple tasks simultaneously. Strong presentation skills to summarize and communicate results. Preferred Experience Experience with equipment/systems commissioning/qualification/validation, deploying new technology into operations, IT/Automation systems. Experience in Cell Gene Therapy (CAR‑T). Other Information Requires up to 10% domestic and/or international travel. This role will start as a hybrid role, with co‑locating at an engineering design firm. Role will transition to site‑based to support installation, qualification, and startup. Anticipated pay range: $100,000 – $170,000. 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 law. We actively seek qualified candidates who are protected veterans and individuals with disabilities. Anticipated base pay range for this position: $100,000 – $170,000. Benefits include: 401(k) retirement plan, long‑term incentive program, paid vacation (120 hours per calendar year), sick time (40 hours per calendar year), holiday pay (13 days per calendar year), work‑personal‑family time (up to 40 hours per calendar year), parental leave (480 hours within one year), condolence leave (30 days for an immediate family member, 5 days for an extended family member), caregiver leave (10 days), volunteer leave (4 days), military spouse time‑off (80 hours). Additional information can be found at Location involves hybrid and site‑based work; domestic travel up to 10%. Employment type: Full‑time. #J-18808-Ljbffr