Assoc. Manufacturing Engineer, Technical Support (3rd Shift)

Legend Biotech USA; Raritan (NJ); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a dedicated Associate Manufacturing Engineer for its Technical Support team. This role is crucial in the development and routine operation of a pioneering CAR-T manufacturing process. You will leverage your technical expertise to resolve manufacturing issues and ensure compliance with quality standards. Collaborating with various teams, you'll drive process improvements and maintain audit readiness. If you're passionate about biotechnology and eager to make a significant impact in a dynamic environment, this opportunity is perfect for you.

Qualifications

• 2-3 years of operations experience in a cGMP biotech/biopharma environment.
• Ability to troubleshoot and resolve complex technical problems.

Responsibilities

• Support the development and operation of a new CAR-T manufacturing process.
• Partner with Quality and Compliance to resolve process issues.

Skills

Technical Support

cGMP Operations

Process Improvement

Troubleshooting

Quality Compliance

Education

Bachelor's degree in Engineering

Advanced degree in Engineering

Job description

Legend Biotech is seeking an Assoc. Manufacturing Engineer, Technical Support (3rd shift) as part of the Technical Operations team based in Raritan, NJ.

Role Overview

The Associate Manufacturing Engineer, Tech Support (3rd Shift) will be part of the Technical Support team and be responsible for supporting the development and routine operation of a new CAR-T manufacturing process. They will serve as a subject matter expert for the manufacturing process and equipment, primarily providing front-line support to address and resolve manufacturing issues.

Key Responsibilities

1. Partner closely with Quality, Compliance, and technical experts to ensure robust and consistent resolution of process issues, maintaining batch quality and adherence to procedures.
2. Support compliant manufacturing investigations and CAPAs as a subject matter expert.
3. Act as a point of contact with equipment suppliers for timely support.
4. Understand key process indicators and support opportunities for process improvement and waste reduction.
5. Perform manufacturing observations to collect process health data and identify improvement opportunities.
6. Serve as a primary point of contact across manufacturing and support organizations, interacting at all levels.

Requirements

1. Bachelor's degree in engineering or related field; advanced degree preferred. Equivalent experience may be considered.
2. 2-3 years of operations experience in a cGMP biotech/biopharma environment; Cell/Gene Therapy experience preferred.
3. Support manufacturing operations with technical expertise.
4. Flexible to work shifts as needed, including 2nd and 3rd shifts.
5. Support process, operational, and quality improvements.
6. Maintain audit readiness and support inspections.
7. Assist in writing SOPs and conducting Quality Risk Assessments.
8. Manage tasks effectively, responding to shifting priorities in a fast-paced environment.
9. Troubleshoot and resolve complex technical problems.
10. Implement process improvements to reduce costs, increase throughput, and ensure quality.
11. Build partnerships with Manufacturing, Engineering, and Quality teams for seamless operations.
12. Willing to work both 2nd and 3rd shifts; initial training on 2nd shift, then move to 3rd shift after 4-6 months.

Conclusion

Legend Biotech is an equal opportunity employer committed to diversity and inclusion. We maintain a drug-free workplace and ensure equal employment opportunities without discrimination based on protected characteristics.