Senior CAR-T Cryopreservation Engineer

Johnson & Johnson Co.; Raritan (NJ); On-site; USD 94,000 - 145,000; Full time

Job summary

The Senior Cryopreservation Process Engineer at Johnson & Johnson leads technical and operational efforts in the Cryopreservation Team, supporting development, scale-up, tech transfer, and readiness of cell processing and cryopreservation manufacturing.

This role spans process engineering, GMP operations, quality, validation, automation, and continuous improvement to enable a compliant, scalable, and cost-competitive commercial facility.

Qualifications

• Minimum of a Bachelor's degree or equivalent in Engineering or related field.
• Minimum of 4 years of relevant professional experience.
• Experience in cGMP manufacturing, operations technology development, technology transfer, process and equipment validation, or quality management.
• Strong startup mindset with ability to identify issues, develop solutions, and drive execution.
• Ability to operate in a fast-paced regulated environment with strong procedural adherence.

Responsibilities

• Provide GMP-based operational expertise for cell and gene therapy technologies.
• Support development and implementation of GMP support processes, including cleaning, environmental monitoring, gowning, waste management, GMP documentation.
• Translate user requirements into operationally efficient processes and support user acceptance testing.
• Provide operational input to facility resource models and leverage capacity models for GMP processes.
• Support change control, risk assessment, qualification, and validation strategies for operational readiness.
• Develop and maintain manufacturing documentation, SOPs, work instructions, and electronic batch records.
• Maintain end-to-end understanding of material, document, waste and sample flows to minimize risk and cross-contamination.
• Lead or support root-cause investigations and regulatory inspections readiness.
• Lead or support IT systems like SAP, MES and automation implementations.
• Develop governance structures to monitor performance during startup and full-scale operations.
• Maintain strong knowledge of manufacturing processes and regulatory frameworks including cGMP and ATMP requirements.

Skills

GMP knowledge

Aseptic processing

Process engineering

Cross-functional collaboration

Problem solving

Automation systems

Education

Bachelor's degree in Engineering or related field

Tools

SAP

MES

Automation systems

Job description

The Senior Cryopreservation Process Engineer at Johnson & Johnson leads technical and operational efforts in the Cryopreservation Team, supporting development, scale-up, tech transfer, and readiness of cell processing and cryopreservation manufacturing.

This role spans process engineering, GMP operations, quality, validation, automation, and continuous improvement to enable a compliant, scalable, and cost-competitive commercial facility.