Principal Cell Therapy Engineer

Principal Cell Therapy Engineer –
Johnson & Johnson Innovative Medicine

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation allows 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 Med Tech, 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.

Supply Chain Engineering

Process Engineering

Scientific/Technology

Horsham, Pennsylvania;
Raritan, New Jersey;
Spring House, Pennsylvania

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.

• Provide operational expertise in the Technical Operations discussions based upon a combination of GMP knowledge of facility design, knowledge in aseptic techniques and process knowledge in development of technology either in ATMPs or equivalent industry that is transferrable 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. Leverage the model to shape the product development and operational processes to deliver solutions for cost competitiveness.
• Lead the development of user requirements for new technology and processes, translate the requirements into operational performance efficiencies and impacts.
• Ensure completion of user acceptance testing to deliver user requirements and performance efficiencies.
• Find opportunities for improvement in your area and lead their development and implementation.
• Immerse yourself in CAR‑T processes, build up proven expertise, ensure timely development and implementation of a robust operational documentation framework, including operating procedures, work instructions, (electronic) batch records, etc., and ensure 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, 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 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.
• As Ops SME, 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 & maintain in depth understanding of the manufacturing processes (incl. sound scientific understanding), operational procedures and manufacturing environment (Facilities, Utilities, Equipment, Systems, Processes)
• Develop & maintain robust understanding of aseptic and cell processing techniques.
• Develop & maintain understanding of relevant regulatory frameworks (general GMP and specific focus on ATMP)
• Understand biosafety.

• Minimum of a Bachelor’s or equivalent University Degree required; advanced degree or focused degree preferred in Engineering, Bioscience Engineering, Industrial…