Senior Cryopreservation Manufacturing Lead

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

Job summary

Johnson & Johnson is seeking a Senior Cryopreservation Process Engineer to lead development, scale-up, technology transfer, and manufacturing readiness for cell processing and cryopreservation operations at our Raritan site in New Jersey. You will apply GMP knowledge and process engineering expertise to enable compliant, reliable, cost-competitive manufacturing.

Collaborate across QA, QC, IT, and operations; own documentation, change control, validation strategies, and continuous improvement.

Qualifications

• Bachelor’s degree in Engineering or related field.
• Minimum of 4 years of relevant professional experience.
• Experience in cGMP manufacturing, operations tech development, transfer, validation, or quality management.
• Ability to collaborate across functions in a matrix organization.

Responsibilities

• Provide GMP-based operational expertise for cell and gene therapy technologies.
• Develop and implement GMP support processes and documentation.
• Translate user requirements into efficient processes and support testing.
• Lead change control, risk assessment, qualification and validation strategies.
• Develop and maintain manufacturing documentation and IT systems integration.

Skills

GMP knowledge

Facility design

Aseptic processing

Cross-functional collaboration

Startup mindset

Problem solving

Education

Bachelor’s degree in Engineering or related field

Tools

SAP

MES

Automation

Job description

Johnson & Johnson is seeking a Senior Cryopreservation Process Engineer to lead development, scale-up, technology transfer, and manufacturing readiness for cell processing and cryopreservation operations at our Raritan site in New Jersey. You will apply GMP knowledge and process engineering expertise to enable compliant, reliable, cost-competitive manufacturing.

Collaborate across QA, QC, IT, and operations; own documentation, change control, validation strategies, and continuous improvement.