Senior Manager, Cryopreservation Process Engineer

Job description

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. 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 areas: cGMP manufacturing, operations technology development, technology transfer, process and equipment validation, or quality management. Demonstrated ability to collaborate effectively across functions and within a matrix organization. Strong startup mindset with the ability to proactively identify issues, develop solutions, and drive execution. Ability to operate effectively in a rapidly changing environment while maintaining flexibility, accountability, and strict adherence to procedures and guidelines. Ability to work independently, prioritize and manage multiple activities simultaneously, and integrate cross-functional issues into effective solutions. Strong technical, analytical, problem-solving, communication, and project-management skills. Preferred Experience: Experience in a plant or commercial manufacturing environment. Experience with equipment and systems commissioning, qualification, and validation (CQV). Experience deploying new technology into manufacturing operations, including IT/automation systems. Cell and gene therapy (CAR-T) manufacturing or cryopreservation experience. Experience with continuous improvement, Lean/Six Sigma, process engineering, and operational excellence. Additional Responsibilities / Capabilities; Agile decision-making and effective issue escalation. Coaching, collaboration, and cross-functional leadership. Corrective and Preventive Action (CAPA), critical thinking, and structured problem solving. Process engineering, product/process improvements, product costing, and supply chain management. 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 vertebras 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 email the Employee Health Support Center (ra-employeehealth