Sr. Manager Engineering
Legend Biotech
September 01, 2026
On-site
Raritan, NJ
IT
Role Overview:
The Senior Manager, Engineering, leads a multidisciplinary engineering organization supporting commercial CARVYKTI cell therapy manufacturing operations. Provides strategic/technical leadership for lifecycle management of manufacturing equipment/systems, process optimization, manufacturing troubleshooting, COGs reduction, and management of a Facilities Investigation Team for non-conformance investigations.
Key Responsibilities:
- Lead, develop, and mentor engineers and investigators supporting cell therapy manufacturing operations.
- Establish goals and performance objectives aligned to site/business priorities.
- Build a culture of safety, accountability, technical excellence, innovation, and continuous improvement.
- Own lifecycle management strategy for manufacturing equipment, utilities, and process systems.
- Ensure equipment reliability, availability, and cGMP/regulatory compliance.
- Oversee qualification, change management, obsolescence planning, capacity planning, and technology upgrades.
- Partner with Validation, Maintenance, and Quality to keep equipment validated and inspection-ready.
- Lead troubleshooting and root cause analysis for equipment/process issues and deviations.
- Identify/implement process optimization and data-driven improvement opportunities.
- Support automation/digital manufacturing initiatives and new technologies.
- Drive cost reduction while maintaining quality, compliance, and patient supply.
- Lead continuous improvement and capital/operational efficiency projects with measurable impact.
- Lead Facilities Investigation Team investigations and CAPA effectiveness.
- Ensure engineering activities comply with cGMP, FDA, EMA, and applicable global regulations; support audits/inspections.
- Participate in risk assessments, change control, and quality management processes; provide technical leadership.
Requirements:
- BS in Engineering (Chemical, Mechanical, Biomedical, Industrial, Electrical, or related) required.
- MS degree or MBA preferred.
- 10+ years in engineering/manufacturing/technical operations/process support in regulated industries (pharma/biotech/biologics/cell therapy).
- 5+ years people leadership managing technical/engineering teams.
- cGMP manufacturing operations experience required.
- Root cause analysis, complex investigations, and CAPA preferred.
- Commercial biologics/advanced therapies/cell therapy manufacturing highly preferred.
- Continuous improvement and cost reduction success.
- Equipment lifecycle management/asset reliability; cell therapy/biologics/aseptic manufacturing; deviation/non-conformance investigations and quality systems.
- Root cause methodologies (Fishbone, 5 Whys, Fault Tree Analysis); process optimization/operational excellence.
- Change control, validation, risk management; regulatory requirements (FDA, EMA, ICH, cGMP).
The Senior Manager, Engineering, leads a multidisciplinary engineering organization supporting commercial CARVYKTI cell therapy manufacturing operations. Provides strategic/technical leadership for lifecycle management of manufacturing equipment/systems, process optimization, manufacturing troubleshooting, COGs reduction, and management of a Facilities Investigation Team for non-conformance investigations.
Key Responsibilities:
- Lead, develop, and mentor engineers and investigators supporting cell therapy manufacturing operations.
- Establish goals and performance objectives aligned to site/business priorities.
- Build a culture of safety, accountability, technical excellence, innovation, and continuous improvement.
- Own lifecycle management strategy for manufacturing equipment, utilities, and process systems.
- Ensure equipment reliability, availability, and cGMP/regulatory compliance.
- Oversee qualification, change management, obsolescence planning, capacity planning, and technology upgrades.
- Partner with Validation, Maintenance, and Quality to keep equipment validated and inspection-ready.
- Lead troubleshooting and root cause analysis for equipment/process issues and deviations.
- Identify/implement process optimization and data-driven improvement opportunities.
- Support automation/digital manufacturing initiatives and new technologies.
- Drive cost reduction while maintaining quality, compliance, and patient supply.
- Lead continuous improvement and capital/operational efficiency projects with measurable impact.
- Lead Facilities Investigation Team investigations and CAPA effectiveness.
- Ensure engineering activities comply with cGMP, FDA, EMA, and applicable global regulations; support audits/inspections.
- Participate in risk assessments, change control, and quality management processes; provide technical leadership.
Requirements:
- BS in Engineering (Chemical, Mechanical, Biomedical, Industrial, Electrical, or related) required.
- MS degree or MBA preferred.
- 10+ years in engineering/manufacturing/technical operations/process support in regulated industries (pharma/biotech/biologics/cell therapy).
- 5+ years people leadership managing technical/engineering teams.
- cGMP manufacturing operations experience required.
- Root cause analysis, complex investigations, and CAPA preferred.
- Commercial biologics/advanced therapies/cell therapy manufacturing highly preferred.
- Continuous improvement and cost reduction success.
- Equipment lifecycle management/asset reliability; cell therapy/biologics/aseptic manufacturing; deviation/non-conformance investigations and quality systems.
- Root cause methodologies (Fishbone, 5 Whys, Fault Tree Analysis); process optimization/operational excellence.
- Change control, validation, risk management; regulatory requirements (FDA, EMA, ICH, cGMP).