Senior Engineer, GMP Facilities & Cell Therapy Ops

Legend Biotech, Inc.

Raritan (IL)

On-site

USD 96,000 - 126,000

Full time

5 days ago
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Benefits offered by this job

Medical insurance
Dental insurance
Vision insurance
401(k) with company match
Paid parental leave
Paid time off

Job summary

Legend Biotech, based in Bridgewater, NJ, is seeking a Senior Engineer for the Facilities & Engineering team in Raritan, NJ. You will oversee GMP facilities, utilities, and cell therapy equipment, driving continuous improvement and regulatory compliance.

Responsibilities include leading investigations, CAPAs, change controls, and cost-reduction initiatives while mentoring junior engineers and coordinating with multiple departments to ensure reliable operations.

Qualifications

  • BS in Mechanical, Electrical, Chemical, Industrial Engineering or related.
  • 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.
  • Strong project management and communication skills.
  • Lean/TPS implementation experience and Operational Excellence leadership preferred.

Responsibilities

  • Provide engineering ownership 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 Cost of Goods Manufactured (COGM) reduction and Operational Excellence (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
Operational Excellence
Mentoring engineers
Lean/TPS

Education

BS in Mechanical, Electrical, Chemical, or Industrial Engineering
MS preferred

Job description

Legend Biotech, based in Bridgewater, NJ, is seeking a Senior Engineer for the Facilities & Engineering team in Raritan, NJ. You will oversee GMP facilities, utilities, and cell therapy equipment, driving continuous improvement and regulatory compliance.

Responsibilities include leading investigations, CAPAs, change controls, and cost-reduction initiatives while mentoring junior engineers and coordinating with multiple departments to ensure reliable operations.

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