Senior, Cryopreservation Process Engineer CAR-T

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 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.

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 Summary:

The Senior Cryopreservation Process Engineer is a key technical and operational leader within the Cryopreservation Team, supporting the development, scale-up, technology transfer, facility design, startup, qualification, and operational readiness of cell processing and cryopreservation manufacturing operations. This role provides cross-functional expertise across process engineering, GMP operations, equipment and facility readiness, quality, validation, automation, and continuous improvement to enable a compliant, reliable, scalable, and cost-competitive commercial manufacturing facility.

Key Responsibilities:

• Provide operational expertise based on a combination of GMP knowledge, facility design, aseptic processing techniques, and process knowledge in the development of technologies for cell and gene therapy products.
• Support development and implementation of GMP support processes, including cleaning, environmental monitoring, gowning, waste management, GMP documentation, and related operational requirements.
• Translate user requirements into operationally efficient processes and support user acceptance testing to ensure systems and processes meet performance, quality, and business requirements.
• Provide operational input to facility resource models and leverage capacity and resource models to shape the development and operability of GMP support processes and deliver cost-competitive solutions.
• Support development and implementation of change control, risk assessment, qualification, and validation strategies to ensure operational readiness and scalability within applicable quality and regulatory requirements.
• Develop and implement robust operational documentation, including standard operating procedures, work instructions, electronic batch records, training materials, and other manufacturing documentation.
• Develop and maintain an end-to-end understanding of material, document, waste, and sample flows; identify risks related to process, contamination, cross-contamination, and mix-ups; and drive improvements in collaboration with Operations, QA, QC, and other functions.
• Act as a technical lead for root-cause investigations and resolution of safety, quality, process, and operational issues within the assigned area.
• Serve as a subject matter expert for the assigned area during health authority and regulatory inspections and support inspection readiness activities.
• Lead or support the design, implementation, and continuous improvement of manufacturing information technology systems, including SAP, MES, automation, and other digital solutions.
• Develop appropriate governance and performance-monitoring structures to assess operational performance during acceptance testing, facility startup, and ongoing commercial operations.
• Develop and maintain a strong understanding of manufacturing processes, including sound scientific principles, operational procedures, and the manufacturing environment covering facilities, utilities, equipment, systems, and processes.
• Develop and maintain strong technical knowledge of aseptic processing and cell processing techniques, as well as applicable regulatory frameworks including cGMP and ATMP requirements and biosafety expectations.
• Support future expansion and site-readiness initiatives, including area readiness, equipment readiness, and operational readiness activities required to enable successful commercial manufacturing batch production.
• Lead and/or support projects related to process improvements, departmental priorities, manufacturing performance, capacity, technology, equipment, quality, and other business needs.
• Provide technical and operational support to the team as needed, including troubleshooting, issue resolution, cross-functional coordination, project execution, and day-to-day manufacturing readiness activities.

Qualifications:

Education

Minimum of a Bachelor's degree or equivalent experience in Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry, or a related scientific or engineering discipline.

Required Experience &

Skills:

• Minimum of 4 years of relevant professional experience.
• Experience in one or more of the following…