CAR-T Manufacturing Engineer: Process & Support

Socket.dev; Raritan (NJ); On-site; USD 78,000 - 103,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid parental leave

Paid time off and holidays

Commuter benefits

Job summary

Legend Biotech in New Jersey seeks an Associate Manufacturing Engineer to support the development and routine operation of a new CAR-T manufacturing process. You will be the subject matter expert for the manufacturing process and equipment, providing front line support to address and resolve manufacturing issues.

You will partner with Quality, Compliance, and technical experts to drive investigations, CAPAs, and process improvements while maintaining audit readiness and contributing to

Qualifications

• Bachelor’s degree in engineering or related field; advanced degree preferred.
• 2–3 years of operations experience in a cGMP biotech/biopharma environment.
• Provide technical support to the Manufacturing team during operations.
• Ability to work shift and adapt to schedule changes as needed.
• Support process, operational, and quality improvements for manufacturing.
• Maintain audit readiness and support inspections.
• Assist in SOP writing and Quality Risk Assessments.
• Manage shifting priorities to meet deadlines in a fast-paced setting.
• Troubleshoot complex scientific/technical problems with the team.
• Support process improvements to reduce costs and improve throughput and quality.
• Collaborate with Manufacturing, Engineering and Quality for daily production.

Responsibilities

• Partner with Quality, Compliance, and subject matter experts to resolve process issues while ensuring batch quality.
• Support compliant manufacturing investigations and CAPAs.
• Serve as a point of contact with equipment suppliers for timely support.
• Understand key process indicators and identify opportunities for improvement and waste reduction.
• Conduct regular manufacturing observations to collect health data for process improvements.
• Act as a primary cross-functional contact across manufacturing and support groups; interact at all levels.

Skills

cGMP operations

Manufacturing support

Troubleshooting

Cross-functional collaboration

Education

Bachelor's degree in engineering

Job description

Legend Biotech in New Jersey seeks an Associate Manufacturing Engineer to support the development and routine operation of a new CAR-T manufacturing process. You will be the subject matter expert for the manufacturing process and equipment, providing front line support to address and resolve manufacturing issues.

You will partner with Quality, Compliance, and technical experts to drive investigations, CAPAs, and process improvements while maintaining audit readiness and contributing to