Senior 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, 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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Malvern, Pennsylvania, United States of America

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 a Cell Processing Staff Engineer to join our team.

The Cell Processing Staff Engineer is part of the Operations Workstream.  This role will act as a decision maker in the Operations Team, with responsibilities to develop and own set-up of supply chain technology and processes for a new facility design.  You will support and implement strategies for change control, risk assessments, and qualification.  By collaborating with various other functions (MSAT, R&D, Engineering, quality assurance, quality control, health and safety, information technology, operations, planning, etc.) you will ensure the successful transfer of the CAR-T process, the timely start of clinical/commercial manufacturing, and scale out of the facility.  The overall goal is creation of a compliant, reliable, and cost competitive commercial facility.

Key Responsibilities:

At the beginning of the facility design, this role will require a broad range of knowledge and will transition to operational readiness and facility startup with ownership of specific areas of the Manufacturing process and all related requirements, including the following responsibilities:

• Provide operational expertise 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 GMP support processes, for instance, cleaning, environmental monitoring, gowning, waste, GMP documentation needs, etc. Translates input into operational performance efficiencies for user requirements for new technology and processes. Ensure completion of user acceptance testing to deliver user requirements and performance efficiencies.

• Provide operational input to the facility resource model.  Leverage the model to shape the development and operability of GMP support processes to deliver solutions for cost competitiveness.

• Support development and implementation of change control strategy, risk assessment strategy, and qualification strategy to ensure operability and scale out considerations within the quality and regulatory requirements.

• Immerse yourself in CAR-T processes, build up solid 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/qu