Senior Cryopreservation Process 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:

Raritan, New Jersey, 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.

There is a pre-identified candidate for this position, but all candidates will be considered.

The Cell Processing Staff Engineer is part of the Cryopreservation team. This role will

act as a decision maker in the cryopreservation 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 cryopreservation process,

the timely start 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, contaminat