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

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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, 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.

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 mfg. 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) an understanding of biosafety,

Qualifications:

Education:

Minimum of a Bachelor’s or equivalent experience in Engineering, Bioscience

Engineering, Industrial Engineering, Pharmacy, Biochemistry or related field.

Required:

Minimum 4 years of relevant work experience.

Experience in one of more of the following areas: cGMP manufacturing,

operations technology development, tech transfer, process and equipment

validation, and/or quality management.

Ability to collaborate internally and externally within a matrix environment.

A start-up/can-do attitude and proactively search for solutions.

Thrive in a rapidly changing environment and lead as a change agent to promote

flexibility, creativity, and accountability while at the same time handling

procedures/ guidelines which require strict execution.

Work independently and successfully, prioritizing and managing multiple tasks

simultaneously, and integrating cross-functional issues.

You are able to concisely summarize and present results.

Preferred

Experience working in a plant manufacturing environment.

Experience with equipment/systems commissioning/qualification/validation.

deploying new technology into operations, IT/Automation systems, cell therapy

(CAR-T) is an asset.

Other

This position supports a dynamic biological manufacturing environment and

may involve working in mechanical spaces and on utility systems or gowning into

Grade B and C environments.

Up to 10% domestic/international travel may be required

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 federal, state or local law. We actively seek qualified

candidates who are protected veterans and individuals with disabilities as defined under

VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of

our applicants’ needs. If you are an individual with a disability and would like to request

an accommodation, please contact us via https://www.jnj.com/contact-us/careers or

contact AskGS to be directed to your accommodation resource.

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 federal, state or local law.

We actively seek qualified candidates who are protected veterans and individuals with

disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of

our applicants’ needs. If you are an individual with a disability and would like to request

an accommodation, please email the Employee Health Support Center (ra-

employeehealthsup@its.jnj.com) or contact AskGS to be directed to your

accommodation resource.

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