Project Engineer

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.  

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Legend Biotech is seeking Project Engineer as part of the Facilities & Engineering team based in Somerset, NJ. 

Role Overview

This position is responsible for supporting the execution of engineering and facility projects and any other projects or initiatives as assigned. Under the direction of senior engineering & operations leaders, this person will support aspects of project initiation, budgeting, design, review of design, scheduling, monitoring, and closure according to GxP, safety and environmental requirements.

Key Responsibilities  

• Support the development, design, coordination, implementation, analysis, reporting, and maintenance of cross-functional projects.
  
• Review and evaluation of new proposals to contribute to bid evaluation process.
  
• Maintains compliance with internal procurement/accounting policies, and purchases, tracks and reconcile items.
  
• Ensures necessary communication within the project engineering team and collaboration with other departments (Manufacturing, Quality, Regulatory, Development, Finance, and IT) on projects/project deliverables.
  
• Provide project updates to engineering leadership and other stakeholders, such as phase gate reviews, meeting minutes, status updates, and identification and tracking of project risks.
  
• Demonstrate effective project management and team collaboration by supporting projects to completion on time, on budget and successfully achieving project expectations in compliance with our safety policies and company regulations.
  
• Coordinate internal resources and third parties/vendors for execution of projects.
  
• Writes, reviews and/or revises Standard Operating Procedures related to Engineering systems and Processes.
  
• Author and/or execute Change Controls for GxP related Engineering/Facilities projects.
  
• Support preparation of Capital Appropriation Requests and/or amendments to facilitate project approval.
  
• Responsible for the execution of safety stops, risk analyses, construction site safety, and correct management of regulatory issues.
  
• Participate in and support facility handover, including turnover documentation to the user organization.
  
• Organize, modify, and maintain architectural, technical and design drawings for the Somerset facility to ensure readiness for regulatory requirements.
  
• Update site’s master drawings and process flows.
  
• Execute work in accord with corporate-wide systems, procedures, and utilize tools to drive efficient management of project responsibilities.
  
• In addition to project activities, this individual may assist in development & implementation of E&F procedures and plans to maintain building and equipment operations
• Initiate, lead and present Capital Appropriation Requests (CAR) to leadership.
  
• Strategize and present plans of action that best fits the business with minimal interruption to operations.
  
• Ability to influence integrity without direct control.
  
• Project execution, including timelines, milestones and resource allocation within budget.

Requirements

• Bachelor's degree in engineering
• 3 years of experience in a regulated industry and 1 year of experience of direct project management preferred
• Knowledge of CAD (example AutoCAD and Bluebeam) is preferred
  
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