Janssen Pharmaceutica is recruiting for the Material Science Engineer for the Manufacturing Excellence CAR-T EMEA organization, located in Ghent Belgium.
The Manufacturing Excellence CAR-T EMEA organization is an organization which provides and supports a high degree of assurance that specific processes will consistently produce and meets its pre-determined specifications by deploying process validation, process system engineering, data architecture and continuous process verification and process investigation.
The team will drive process optimizations to enable seamless transition from clinical to commercial operations.
- Will deploy the competence center for direct and indirect manufacturing materials on cell therapy processes.
- Provides guidance and execution on aspects of material experiments for manufacturing process equipment as part of the equipment characterization
- Assure material expertise in case of improvements or post-investigation activities.
- Write, review and approval of material related characterization protocols, reports and master data sheets upfront of equipment qualification.
- Will support the material release labs with all technical details, will drive in depth investigations with suppliers in case of non-conformances.
- Will support R&D department in introducing new technologies for specific type of materials, sharing global platform competences and/or introducing best practices from other manufacturing facilities.
- Perform upgrades to and support the implementation of new process supplies, materials and contribute on process systems
- Implement or propose alterations, modifications, or replacement of existing supplies to improve process reliability and reduce overall equipment lifecycle costs and process downtime
- Identify and provide support for the implementation of new and innovative cost & quality improvement initiatives for the successful development of business opportunities as required
- Support the creation of new practices, policies and procedures (e.g., SOPs, Work Instructions, etc.) pertaining to Operations, Engineering and Maintenance to enhance the performance of the business
- Support process driven quality events including (but not limited to):
Deviations/Investigations, Out of Tolerances (OOTs), Change Controls, CAPAs, Root Cause Analysis and FMEA
- Participate in system and process improvement / optimization projects
- Reviews technical reports and other sources of information to ensure that master data sheets, product release protocols and procedures are consistent with current industry, regulatory requirements, and current technology
- Support process investigations with accurate knowlegde and competences.
- A Bachelor degree in Engineering (Chemical, Bio), or equal in Biomedical Sciences or Pharmacy is required
- A minimum of five (5) years of experience in process engineering or operations within an farmaceutical manufacturing or regulated environment is preferred.
- Experience in a controlled pharmaceutical cleanroom environment under aseptic conditions is preferred.
- A good understanding of material science, process equipment, manufacturing processing and computerized systems within an pharmaceutical manufacturing or regulated environment. Experience in the Pharmaceuticals, Biotechnology, Cell Therapy, human plasma derived products or related industry is required.
- Experience with introduction of pharmaceutical products to manufacturing sites and late state development with working technical knowledge of manufacturing site unit operations
- Strong analytical, problem solving and critical thinking skills
- Ability to identify/remediate gaps in processes, equipment, facilities and business systems and to troubleshoot problems for highly technical equipment.
- Strong working knowledge of current Good Manufacturing Practices (cGMP).
Experienced in working with validated and qualified process equipment and systems, and associated documentation.
- Provide timely and accurate reporting on project activities to peers and leadership
- Able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment. Entrepreneur mentality preferable.
- Available for other duties and demonstrate willingness to learn new skills as required
- Ability to interact with all levels within the organization and build strong partnerships with Operations, Global Engineering and Quality
- Transparent, passionate, responsible and accountable, handle conflicting interests and take decisions
- Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly
- Team player
- Problem solving skills and attitude
- Fluent in written and spoken dutch and english