Facility Engineer

Legend Biotech is seeking a Facility Engineer as part of the Facilities & Engineering team based in Raritan, NJ.

Role Overview

This position will be responsible for facilities engineering support, design, and implementation for mechanical systems and equipment, and work order management for cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with various Technical Operation functions in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This individual will support the organization in its build and ramp-up of clinical production and facility approval of a state-of-the-art cell therapy facility for commercial launch and sustained production. The role will require proven leadership and expertise that drives effective communication, coordination and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients.

Key Responsibilities

• Demonstrates professional execution of the planning, development, and implementation of construction and/or repair programs for engineering driven initiatives.
  
• Serves as SME on engineering design projects; sets project requirements, evaluates compliance with project and engineering standards, and approves final designs and installations.
  
• Identifies, investigates, and analyzes a wide range of complex facilities, utilities, systems, equipment or manufacturing issues and develops a robust solution for remediation.
  
• Oversees, reviews, and approves the work of external engineering design and planning consultants; ensures that engineering designs are consistent with contract specifications and all relevant regulations and engineering standards.
• Supports the review of equipment, building, and other job plans within the CMMS for effectiveness, applicability, and compliance. Ensure all equipment is operated and maintained within a validated/qualified/certified state.
  
• Gathers and analyzes data, blueprints, and reports.
  
• Supports tracking and achievement of annual maintenance goals and objectives including metric improvement targets. Support continuous improvement activities such as preventive maintenance optimization, risked based asset management programs, and analyze equipment for proper balance of preventive to corrective work order ratio.
  
• Supports maintenance driven quality events including but not limited to Deviations/Investigations, Out of Tolerances (OOTs), Change Controls, Root Cause Analysis and FMEA’s.
  
• Ensures regulatory and job training remains current by promptly completing required training.
  
• Complies with all company and/or site policies and procedures.
  
• Demonstrates willingness to learn new skills as required.
  
• Available for other duties as required.
  
• Ensures site compliance with all local, state and federal regulations including and equivalent to Federal Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), and Drug Enforcement Agency (DEA) as applicable (TSA) Transportation Security Administration.
  
• Ability to work independently and with minimal guidance/oversight.
  
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.

Requirements

• B.Sc./M.Sc. in mechanical, electrical, or industrial engineering.
• Minimally 5+ years of experience as a facility engineer or working within an industrial manufacturing or regulated environment is required, ideally has cGMP cleanroom manufacturing experience under aseptic conditions
• Experience with a CMMS or similar maintenance management system is preferred
• Experience with AutoCAD, SAP, and MS Office.
• Proficiency in English (verbal and written) and strong communication skills
• cGMP manufacturing familiarity is preferred
• Ability to apply engineering principles and techniques to the solution of equipment, buildings, and infrastructure.
• Knowledge of architectural designs, building codes, construction/project management principles.

#Li-RN1

#Li-Onsite