Commissioning & Qualification (C&Q) Engineer

Company Information

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 and natural killer (NK) cell-based immunotherapy.

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) in 2017. 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.

Position Overview

This position is part of the Engineering and Maintenance team within the Technical Operations group and is responsible for performing Commissioning and Qualification (C&Q) activities within the cGMP Clinical and Commercial Cell Therapy Manufacturing plants in Ghent, Belgium. In addition to this primary focus, the role involves managing capital investments and continuous improvement projects. This individual will handle day-to-day activities, including execution, protocol management, vendor management, issue resolution, deviations, corrections, and remediation efforts for equipment and systems in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. The role requires project management skills, C&Q, and general engineering experience, along with the ability to work independently and drive effective communication, coordination, and collaboration across relevant cross-functional groups to establish a strong, compliant C&Q program to enable robust production, testing, and release of products to patients.

Major Responsibilities

• Execute commissioning, qualification, requalification, and associated engineering activities within the plants.
• Manage multiple and complex C&Q projects, provide status reports, and coordinate with other departments or outside contractors/vendors to complete tasks.
• Support and/or own technical and quality investigations related to C&Q.
• Develop and perform any required remediation efforts and associated CAPA plans.
• Author, own, and execute master and completed C&Q protocols, summary reports, and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria, specifically data integrity.
• Execute, own, assess, and participate in the creation, revision, and review of change controls, SOPs, and other documentation.
  
  

Qualifications

Education:

• A minimum of a Master’s Degree in Science, Engineering, Bioengineering, or an equivalent technical discipline is required.
  
  

Experience:

• A minimum of 2 years of relevant work experience within a cGMP environment is required. Experience working in an aseptic manufacturing facility is preferred.
  
  

Capabilities, Knowledge, and Skills:

• Knowledge of cGMP regulations and FDA/EU guidance related to the manufacturing of cell-based products, as well as knowledge of Good Tissue Practices.
• A good understanding of technical installations, P&IDs, equipment, and (computerized) systems within the Life Science Industry.
• Strong interpersonal and written/oral communication skills.
• Ability to quickly process complex information and often make critical decisions with limited information.
• Ability to independently manage a portfolio of ongoing projects.
• Attention to detail and adherence to procedures.
• Highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Good written and verbal communication skills are required.
• Ability to summarize and present results, with experience in team-based collaborations.
• Proficiency in applying process excellence and QRM tools and methodologies.
• Ability to identify and remediate gaps in processes or systems.
• Experience authoring and executing documentation including, but not limited to, electronic batch records, SOPs, Work Instructions, and C&Q protocols.
  
  

Language(s):

• English/Dutch
  
  

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

Legend Biotech maintains a drug-free workplace.