Senior GMP Facilities Engineer - Cell Therapy

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

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan with company -

Eight weeks paid parental leave

Vacation, personal time, sick time, 11

Commuter benefits

Job summary

Legend Biotech USA, Inc. is seeking a Senior Engineer in Raritan, NJ to provide technical leadership for GMP facilities, utilities, and cell therapy manufacturing process equipment. You will partner with Manufacturing, Quality, Validation, Facilities, and Maintenance to ensure reliable operation and ongoing improvements.

The role requires a BS in engineering (MS preferred) and 7+ years in a GMP environment, with strong project management and mentoring abilities to drive operational excellence.

Qualifications

• BS in Mechanical, Electrical, Chemical, Industrial Engineering or related; MS preferred.
• 7+ years in engineering, facilities, maintenance, or operations in a GMP environment.
• Biotech/pharma/cell therapy manufacturing experience 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.

Responsibilities

• Own lifecycle management for GMP facilities, utilities, and cell therapy manufacturing process equipment.
• Lead troubleshooting, root cause investigations, deviation support, CAPAs, and change controls.
• 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

GMP facilities ownership

Project management

Cross-functional collaboration

Lean/Operational Excellence

Mentoring

Communication skills

Problem solving

Multiple priorities

Education

BS in Engineering

MS preferred

Job description

Legend Biotech USA, Inc. is seeking a Senior Engineer in Raritan, NJ to provide technical leadership for GMP facilities, utilities, and cell therapy manufacturing process equipment. You will partner with Manufacturing, Quality, Validation, Facilities, and Maintenance to ensure reliable operation and ongoing improvements.

The role requires a BS in engineering (MS preferred) and 7+ years in a GMP environment, with strong project management and mentoring abilities to drive operational excellence.