Senior Engineer, GMP Facilities & Cell Therapy Ops

BioSpace; 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 1:

Eight weeks paid parental leave

Extensive paid time off including 11公司

Job summary

Legend Biotech in Bridgewater, New Jersey, seeks a Senior Engineer for facilities, utilities, and cell-therapy equipment leadership. You will partner with manufacturing, quality, validation, facilities, supply chain, automation, and maintenance to ensure reliable, compliant operation and continuous improvement.

The role requires a BS in engineering with 7+ years in GMP settings, strong project management, and mentoring skills.

Qualifications

• BS in engineering, MS preferred.
• 7+ years in GMP-regulated engineering, facilities, maintenance, or operations.
• Strong project management and communication skills.

Responsibilities

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

Skills

Project management

Communication

Mentoring

Lean/TPS

Education

BS in Mechanical, Electrical, Chemical, Industrial Engineering or related field; MS preferred

Tools

CAPA management

Change control

Deviation management

GMP knowledge

Job description

Legend Biotech in Bridgewater, New Jersey, seeks a Senior Engineer for facilities, utilities, and cell-therapy equipment leadership. You will partner with manufacturing, quality, validation, facilities, supply chain, automation, and maintenance to ensure reliable, compliant operation and continuous improvement.

The role requires a BS in engineering with 7+ years in GMP settings, strong project management, and mentoring skills.