Commissioning & Qualification (C&Q) Engineer

Job Description

Legend Biotech is seeking a Commissioning & Qualification (C&Q) Engineer to join their Engineering and Maintenance team in Ghent, Belgium. This role is within the Technical Operations group and focuses on performing C&Q activities within the cGMP Clinical and Commercial Cell Therapy Manufacturing plants. The C&Q Engineer will also manage capital investments and continuous improvement projects, ensuring safe and compliant manufacturing operations according to cGMP requirements. The role involves 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.Responsibilities:

• Executing commissioning, qualification, requalification, and associated engineering activities within the plants.
• Managing multiple and complex C&Q projects, providing status reports, and coordinating with other departments or outside contractors/vendors to complete tasks.
• Supporting and/or owning technical and quality investigations related to C&Q.
• Developing and performing any required remediation efforts and associated CAPA plans.
• Authoring, owning, and executing 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.
• Executing, owning, assessing, and participating in the creation, revision, and review of change controls, SOPs, and other documentation.

Requirements:

• A minimum of a Master’s Degree in Science, Engineering, Bioengineering, or an equivalent technical discipline is required.
• A minimum of 2 years of relevant work experience within a cGMP environment is required.
• Experience working in an aseptic manufacturing facility is preferred.
• 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.
• English/Dutch language skills