Senior Manager, Cryopreservation Process Engineer

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Supply Chain Manufacturing

Production Equipment Repair & Maintenance

Professional All

Raritan, New Jersey, United States of America

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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 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…