Senior Engineer, GMP Facilities & Cell Therapy

Legend Biotech, Inc.; Raritan (NJ); On-site; USD 96,000 - 126,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

8 weeks parental leave

PTO including vacation/personal/sick/9

Flexible spending accounts

Health savings accounts

Life and AD&D insurance

Disability coverage

Pet insurance

Commuter benefits

Well-being initiatives

Peer-to-peer recognition

Job summary

Legend Biotech, a global biotechnology company, seeks a Senior Engineer to lead facilities, utilities, and process equipment for commercial cell therapy manufacturing in Raritan, NJ. You will partner with Manufacturing, Quality, Validation, Facilities, Supply Chain, Automation, and Maintenance to ensure reliable, compliant operations and drive continuous improvement.

The role requires a BS in engineering, 7+ years in a GMP setting, and experience with commissioning, validation, and change

Qualifications

• BS in Mechanical, Electrical, Chemical, Industrial Engineering or related field; MS preferred.
• 7+ years of engineering, facilities, maintenance, or operations experience in a GMP-regulated environment.
• Experience supporting biotechnology, pharmaceutical, or cell therapy manufacturing preferred.
• Experience leading equipment and utility projects from concept through implementation.
• Knowledge of commissioning, qualification, validation, change control, and deviation management processes.
• Strong project management and communication skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Experience mentoring engineers and leading cross-functional initiatives.
• Proven Lean/TPS implementation experience and Operational Excellence leadership experience preferred.

Responsibilities

• Provide engineering ownership and lifecycle management for GMP facilities, utilities, and cell therapy manufacturing process equipment.
• Lead troubleshooting, root cause investigations, deviation support, CAPAs, and change controls for manufacturing equipment and support systems.
• Identify, lead, and deliver COGM reduction and OpEx initiatives.
• Develop and optimize preventive and predictive maintenance strategies.
• Support commissioning, qualification, validation, startup, and turnover activities.
• Monitor system performance and identify improvement opportunities.
• Author and review SOPs, technical reports, and specifications.
• Lead cross-functional projects and manage contractors and vendors.
• Ensure compliance with cGMP, EHS, and regulatory requirements.
• Support audits and inspections.
• Mentor junior engineers.

Skills

Project management

Communication skills

Mentoring engineers

Cross-functional leadership

Operational Excellence

Lean/TPS implementation

Education

BS in Mechanical/Electrical/Chemical/Industrial Eng

Job description

Legend Biotech, a global biotechnology company, seeks a Senior Engineer to lead facilities, utilities, and process equipment for commercial cell therapy manufacturing in Raritan, NJ. You will partner with Manufacturing, Quality, Validation, Facilities, Supply Chain, Automation, and Maintenance to ensure reliable, compliant operations and drive continuous improvement.

The role requires a BS in engineering, 7+ years in a GMP setting, and experience with commissioning, validation, and change