Process Engineer
il y a 2 semaines
Just-Evotec Biologics is seeking a highly motivated Process Engineer - New Product Introduction and Scale-up to lead activities related to the introduction of new products to the J.POD Toulouse biotherapeutics manufacturing facility. The role will provide cross-functional interactions for all phases of Just-Evotec's NPI process, from project initiation through process validation and registration activities.
The role will require close collaboration with all functional areas of the J.POD Toulouse team, including Product and Process Design, Process Engineering, Process Automation, Quality Controls, Quality Assurance, Supply Chain, Manufacturing, Digital, and EHS. The role will participate in client-facing meetings to discuss topics related to NPI activities.
Key Responsibilities:
- Leading the NPI process at J.POD Toulouse to support the start and rapid scale-up of commercial GMP manufacturing activities
- Partnering with Product and Process Design to coordinate successful efficient scale-up and transfer operations and to ensure the successful integration of process knowledge into manufacturing operations
- Partnering with Supply Chain to support Downstream Bill of Material development and demand planning for new products
- Partnering with Process Engineering and Digital disciplines to conduct facility fit assessments and plans to support system updates needed for new product introduction
- Partnering with Manufacturing to develop high-quality batch records, robust processes, and innovative technology solutions for new product introduction
- Partnering with Quality, CQV, and Global MSAT to develop and implement process validation and comparability study activities leading to successful product registration
- Acting as a subject matter expert to support the team for regulatory and client inspection audits
- Utilizing the team's technical skills and process knowledge to participate in investigations related to Downstream NPI activities. Collaborating with impacted groups to develop and execute effective CAPA
- Applying Operational Excellence principles to lead continuous improvement in NPI activities
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