Position Overview

This position will be part of the CAR-T Asset Management team within the Technical Operations group and will be responsible to support Commissioning and Qualification activities within the cGMP Clinical and Commercial Cell Therapy Manufacturing plants in Ghent (Belgium).This individual will be responsible for handling day-to-day administrator activities for both CAR-T Ghent facilities inclusive of managing users, extracting audit trails, periodic deleting of files, making back-ups on computerized GMP systems.This role will require a general GMP mindset and a strong ability to autonomously organize, execute and document administrative tasks to support business continuity.

Major Responsibilities

• Responsible for organizing and execution in the cleanrooms of day-to-day administrator activities on computerized systems inclusive of adding/removing users, extracting audit trails, execution of periodic deleting of files, making back-ups and corresponding documentation according to Good Documentation Practices
• Responsible for making run data exports to a centralized location upon operational request
• Keeping oversight of all user access requests and maintaining corresponding mailbox
• Keeping oversight on segregation of duties when following up on user access requests
• Following-up on archival of user access request forms
• Supports in paper and digital archival of executed C&Q documentation and tracks oversight
• Supports in collecting prerequisite documentation needed for execution of C&Q and periodic review activities
  
  

Qualifications

Education:

Graduate or Bachelor’s Degree in Science, Engineering, Bioengineering or equivalent technical discipline is preferred

Experience:

A minimum of 1 year experience within a regulated environment is preferred.

Capabilities, Knowledge, and Skills:

• Proficient user of Microsoft Office applications (Word, Excel, PowerPoint, and Outlook)
• Right-first-time mindset is required
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously and balance competing priorities effectively
• Flexible mindset to guarantee business continuity
• Clear verbal and written communication skills
• Ability to pay attention to details and follow the procedures
• The candidate must be highly organized
  
  

Language(s):

Dutch, English

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.