Asset Engineer

Asset Engineer - CAR-T (Belgium)
Location: Gent area, Belgium

We are supporting a leading cell therapy manufacturer in hiring an Asset Engineer to strengthen their CAR T engineering team. In this role you will provide technical expertise for lab and process equipment used in the CAR T manufacturing process and support commissioning and qualification (C&Q) activities within cGMP clinical and commercial cell therapy facilities.

The role

As Asset Engineer you are a key contributor to reliable operations and asset lifecycle management. You work closely with project teams, vendors and site stakeholders to ensure equipment is introduced, qualified and maintained in line with global and local standards.

Responsibilities

• Manage multiple equipment-related business requests and small projects via the change control quality system.

• Support and execute operational commissioning and qualification (C&Q) activities in line with global processes.

• Act as Asset Subject Matter Expert (SME) for CAR T equipment.

• Contribute to the creation and review of technical requirements and asset standards.

• Provide guidance on compliance and data integrity requirements.

• Identify and address gaps between global and local compliance processes and drive consistent technical practices across CAR T sites.

• Develop and maintain strong strategic relationships with key vendors.

• Drive continuous technical improvements across the asset base.

• Coordinate with internal departments and external suppliers to resolve technical issues and drive solutions.

• Support technical investigations during C&Q activities and day to day operations.

• Lead evaluation, business case development and implementation of new asset technologies.

Your profile

• Master’s degree in Science, Engineering, Bioengineering or a similar technical discipline.

• 3+ years of experience in a pharmaceutical manufacturing and/or engineering environment.

• Proven experience with commissioning & qualification (C&Q) of equipment.

• Solid understanding of data integrity requirements (e.g. 21 CFR Part 11).

• Strong stakeholder management and communication skills.

• Proactive, structured and comfortable managing multiple initiatives in a GMP setting