Senior Manager, 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 Manufacturing Job Sub Function: Production Equipment Repair & Maintenance Job Category: Professional All Job Posting Locations: Raritan, New Jersey, United States of America Job Description: 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 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.

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