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 Med Tech, 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

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.

• 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.

• 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…