Material Science Engineer

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.

Key Responsibilities

• 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.