Assets Engineer

Are you passionate about improving the lives of cancer patients? We work on the most sophisticated treatment options available today! CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. They are created from the patients’ own T cells and are engineered to eliminate cancer cells expressing a specific antigen.
To support the CAR-T program in EMEA, Janssen is building two CAR-T manufacturing centers in the Ghent area (Belgium) and new build Lab’s and warehouse will be operated from the existing Janssen Beerse site. We are establishing the Engineering & Technical Services organization which will provide ownership and oversight for the entire asset portfolio and associated business processes for Janssen’s Advanced Therapies Supply Chain globally.
Along the lifecycle of our assets, such as facilities, equipment and utilities, this role is the key point of contact for all technical matters. It is responsible for providing technical expertise, leveraging best practices, and developing internal as well as external partnerships within the CAR-T EMEA program serving the Beerse and the Ghent sites. The role will be a key contributor to ensure flawless operation and asset replacement projects in close collaboration with the different project organizations, vendors, sites, and stakeholders. In addition, the role holder creates and sustains continuous technical improvements around our asset base and supports troubleshooting as needed. The ideal candidate will possess a strong track knowledge in Cell-and-Gene Therapy assets or related technical field, operations support role in the Biopharm/Large Molecule sector. Proactive communication and a willingness to be hands-on in key aspects of technical matters will round up the profile. The role requires daily partnering with Operations, Quality, and 3 rd party partners as well as Environment Health & Safety.

Tasks and Responsibilities

• Drives the standards for the asset portfolio and provides asset ownership as a service for production/laboratory equipment, facilities, and utilities
• Accompanies all stages of a typical asset lifecycle and makes sure best business practices are in place and adhered to
• Supports resolving of technical issues or roadblocks as fast as possible incl. lessons learned
• Creates or supports the writing of URSs, Change Controls, Impact Assessments, technical evaluations, and operational documents etc.
• Supports investigations, deviations, corrective and preventive actions towards successful timely and compliant closure
• Participate in compliance inspections/audits within area of responsibility
• Ensures compliance with all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WI’s and Company policies and corporate standards
• Supports the asset replacement planning process as well as vendor evaluation/selection
• Actively communicates regularly with the broad asset stakeholder’s community and fosters expertise sharing with CAR-T entities around the globe