Senior Cryopreservation Process Engineer — Scale-Up & Tech Transfer

jj; Raritan (NJ); On-site; USD 94,000 - 145,000; Full time

Job summary

Johnson & Johnson is seeking a Senior Cryopreservation Process Engineer to lead technical and operational efforts in cryopreservation manufacturing, supporting development, scale-up, tech transfer, and facility readiness for cell processing and GMP operations.

The role requires collaboration across engineering, QA, QC, and IT, with a strong focus on safety, quality, and continuous improvement to enable cost-effective commercial manufacturing.

Qualifications

• Minimum of 4 years of relevant professional experience.
• Experience in cGMP manufacturing, operations technology development, technology transfer, process and equipment validation, or quality management.
• Ability to collaborate 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 in a rapidly changing environment while maintaining flexibility and adherence to procedures.

Responsibilities

• Provide operational expertise based on GMP knowledge, facility design, aseptic processing, and process knowledge for cell and gene therapy products.
• Support development and implementation of GMP support processes (cleaning, environmental monitoring, gowning, waste management, GMP docs).
• Translate user requirements into operationally efficient processes and support testing to meet performance and quality needs.
• Provide input to facility resource models and shape GMP support processes for cost-effective solutions.
• Support change control, risk assessment, qualification, and validation strategies for readiness and scalability.
• Develop and maintain manufacturing documentation (SOPs, work instructions, eBRs, training materials).
• Maintain end-to-end understanding of material, document, waste, sample flows; identify risks and drive improvements.

Skills

cGMP manufacturing

Technology transfer

Process validation

Quality management

Cross-functional collaboration

Startup mindset

GMP

Data analysis

Problem solving

Project management

Education

Bachelor's degree or equivalent

Job description

Johnson & Johnson is seeking a Senior Cryopreservation Process Engineer to lead technical and operational efforts in cryopreservation manufacturing, supporting development, scale-up, tech transfer, and facility readiness for cell processing and GMP operations.

The role requires collaboration across engineering, QA, QC, and IT, with a strong focus on safety, quality, and continuous improvement to enable cost-effective commercial manufacturing.