Position Overview
This position will be part of the CAR-T Asset Management team within the Technical Operations group and will be responsible for performing and coordinating Commissioning and Qualification activities within the c GMP Clinical and Commercial Cell Therapy Manufacturing plants in Ghent (Belgium).This individual will be responsible for leading and overseeing day-to-day C&Q activities inclusive of protocol management & execution, management and periodic review of user access and audit trail, periodic system quality review for CAR-T process and lab equipment in support of personalized cell therapy production through safe and compliant manufacturing operations according to c GMP requirements. This role will require people management skills, engineering and C&Q experience, ability to work independently, drive effective communication, coordination and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients.
Major Responsibilities

• Responsible for leading and overseeing day-to-day C&Q activities inclusive of protocol management & execution, management and periodic review of user access and audit trail, periodic system quality review for CAR-T process and lab equipment in support of personalized cell therapy production through safe and compliant manufacturing operations according to c GMP requirements.
• Manages multiple and complex C&Q projects, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks.
• Prioritize the use of internal and external resources to most effectively achieve business goals and within budget.
• Develop, lead & coach a team of C&Q Engineers to ensure that all critical production process and lab equipment and systems (assets) in all areas of responsibility comply with all company and/or site Quality & EHS policies and procedures, user requirements, local and federal regulations (e.g., FDA/EU c GMP) and industry standards, guidance and expectations.
• Maintain knowledge of and compliance to all applicable codes and regulations as required.
• Responsible for the planning, execution, tracking and reporting of status and risks/issues associated with C&Q activities for CAR-T production process and lab equipment.
• Coordinates with other departments and/or outside contractors/vendors (if applicable) in case of issues
• Supports in authoring CARA documents (Critical Aspects Risk Assessments), T&TM's (Test & Traceability Matrices), Periodic Qualifications, Project Plans, Master Plans, and PSQR's (Periodic System Quality Reviews).
• Supports in execution of commissioning, qualification, requalification and any associated engineering activities within the plants.
• Supports and/or owns technical investigations detected during C&Q activities.

Qualifications:
Education

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

Experience

• A minimum of 3 years relevant C&Q and people oriented work experience within a c GMP environment. It is preferable that the candidate has experience working in an Aseptic manufacturing facility.

Capabilities, Knowledge, and Skills

• Proven people management skills.
• Detailed knowledge and understanding of c GMP, FDA/EU and Industry regulations, standards, guidance and expectations.
• A thorough understanding of Good Engineering Practices (GEP), technical installations, equipment, facilities and (computerized) systems within the Life Science Industry.
• Ability to work independently and successfully, prioritize and manage multiple projects and tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• Ability to pay attention to details and follow procedures.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Strong interpersonal and written/oral communication skills are required.
• Ability to summarize and present results, and experience with team-based collaborations is a requirement.
• Proficient in applying process excellence and QRM tools and methodologies.
• Build strong partnerships with Operations, Manufacturing Excellence and Quality to ensure seamless implementation of Engineering and Maintenance projects and/or process improvements.
• Ability to identify/remediate gaps in processes, equipment, facilities and systems.
• Experience in authoring and executing documentation including, but not limited to: (electronic) Batch Records, SOPs, Work Instructions, C&Q documents.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Power Point).
• Experience with SAP, Change Control system and DMS is preferred.

Language(s)

• Dutch/English