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.
This role is responsible for providing technical in-depth expertise, leveraging best practices, oversight and developing internal as well as external partnerships with focus on Maintenance and Calibration (M&C) within the CAR-T EMEA program serving the Beerse and the Ghent sites. The role will oversee the day-to-day business of M&C activities and ensure flawless liaison with the different teams, vendors, sites, and stakeholders. In addition, the role holder creates and sustains continuous procedural improvements to boost efficiency of M&C activities. The ideal candidate will possess a strong track record in manufacturing asset maintenance as well as calibration, business acumen, proactive communication, and a willingness to be
hands-on in key aspects of M&C tasks. The role requires the development of strong partnerships and strong interfacing with Operations, Quality, Environment Health & Safety as well as 3 rd party partners.
Tasks and Responsibilities :
- Ensures flawless execution of planned preventive and corrective maintenance and calibration activities for manufacturing and laboratory equipment as well as facilities and utilities
- Drives the establishment of a holistic, balanced RCM-based M&C strategy across the asset portfolio including the translation into execution and continuous improvement
- Ensures that technical issues or roadblocks are anticipated and resolved as early, and as fast as possible incl. lessons learned
- Supports investigations, corrective and preventive actions towards successful timely and compliant closure
- Ensures M&C activities follow all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WI’s and Company policies and corporate and technical standards
- Provides technical leadership and act as true expert for M&C
- Participate in compliance inspections/audits within area of responsibility Manage partnerships with contractors and vendors
- Establishes and manages KPI’s and tracking tools across the scope
- Actively communicates regularly with project leads and project delivery stakeholders
- Responsible for supervising engineers and specialists at the sites by driving a Credo-based culture aligned around our guiding principles of servant leadership, Think Differently, Do Better, innovation, engagement, collaboration and development.
- Degree in Engineering, Science or related discipline; Masters preferred.
- 8-10 years of experience in pharmaceutical plant based or service provider role
- A minimum of 5 years in leading maintenance and calibration activities
- A minimum of 3 years in executing maintenance and calibration activities
- Previous exposure to international health authority inspections as well as internal and external audits
- Self-driven and able to set own targets and able to set priorities under pressure
- In depth knowledge of guidelines and codes related to equipment, utilities and facilities (e.g. ISO, EN, ISPE) and applicable current GMP requirements (e.g. ICH, FDA, FAGG/FAMHP)
- Previous experience working in a large matrix-managed environment preferred
- Previous in-depth experience with SAP/PM is a must
- Fluent in English (written and spoken), Dutch language at level C1 preferred
- Proactive, open team player with a service mindset
- Working regimen is approx. 60% Ghent, 30% Beerse, 10% travels