Position Overview

This position is part of the CAR-T Asset Management team within the Technical Operations group and is responsible for Subject Matter Expert (SME) responsibilities for assets within the cGMP Clinical and Commercial Cell Therapy Manufacturing plants in Ghent, Belgium. In addition to this primary focus, this position will lead or support continuous improvement projects. The individual will handle day-to-day activities including qualification management, vendor management, issues, deviations, corrections, and remediation efforts for production processes, lab equipment, and systems (assets) in support of personalized cell therapy production. This must be done through safe and compliant manufacturing operations according to cGMP requirements. This role requires project management skills, C&Q, and general engineering experience. The candidate must work independently and drive effective communication, coordination, and collaboration across relevant cross-functional groups to establish a strong, compliant engineering program to enable robust production, testing, and release of products to patients.

Major Responsibilities

• Act as a subject matter expert (SME) for assigned assets within the plants.
• Serve as an administrator for assigned systems within the plants and follow up on user access requests.
• Execute Periodic Audit Trail Review and User Access Review in a timely manner.
• Execute Periodic System Quality Reviews timely and take appropriate action.
• Participate in authoring and reviewing CARA documents (Critical Aspects Risk Assessments), T&TM’s (Test & Traceability Matrices), Project Plans, and Master Plans.
• Participate in authoring and reviewing C&Q protocols, summary reports, and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria, particularly data integrity.
• Support and review the commissioning, qualification, requalification, and any associated engineering activities within the plants.
• Manage multiple and complex engineering 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 assets.
• Develop and perform any required remediation efforts and associated CAPA plans.
• Execute, own, assess, and participate in the creation, revision, and review of change controls, SOPs, and other documentation.
• Participate in operational meetings.

Qualification

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 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 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.
• Ability to summarize and present results, and experience with team-based collaborations.
• Proficient 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, C&Q protocols.
• Experience with ERP (SAP), CMMS (SAP PM), QTS (TrackWise), and DMS/LMS is preferred.

Language(s):

• Dutch/English

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