CONTINUED PROCESS VERIFICATION ENGINEER
Descripción de la oferta de empleo
Patient’s T-cells are genetically modified to eliminate cancer cells.
This ground-breaking technology provides hopeful prospects to patients where other therapies have failed or fail to provide adequate results.
Janssen Biotech, Inc.
entered into a global collaboration agreement with Legend Biotech to develop, manufacture and commercialize (CAR) T-cell therapy.
This partnership is designed to combine the strengths and expertise of two companies to deliver on the promise of a CAR T platform for immunotherapy and investigational treatment.
To support the CAR-T program in EMEA, we are working with great enthusiasm on expanding our capacity.
The CPV engineer is part of the Manufacturing Excellence team and closely connected to the Tech Transfer workstream.
Key responsibilities - You will be responsible for monitoring the manufacturing process according to Process Validation and Continued Process Verification requirements - You will be responsible for reviewing the raw data and statistical analyses, analyze out of trends, out of specs and other process parameters - Write, review and approval of CPV protocols and reports - You will provide technical leadership by effectively interfacing and collaborating with IT business system owners - You will pro-actively identify process improvements and optimizations opportunities - You will strategically prepare for optimizations in the batch documentation process domain - You will act as a spokesperson for your area during health care inspections Qualifications Experience - It is preferable to have relevant work experience Skills - You have a Bachelor or Master’s Degree in a scientific or technical field (Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry …) - You have a start-up/can-do mindset, and you proactively search for solutions - You thrive in a rapidly changing environment and lead as a change agent to promote flexibility, creativity, and accountability while at the same time handling procedures/guidelines which require strict execution - You work independently under general direction, having a good sense of prioritization and managing multiple tasks simultaneously - Your verbal and written communication skills enable you to influence without authority - You embrace diversity, equity, and inclusion Our offer - The opportunity to participate in a progressive treatment that gives hope to patients in need - The ability to shape a new venture from the start and work in an innovative working environment - Opportunities to continue to develop and grow in an extensive and strong organization
Detalles de la oferta
- Sin especificar
- En toda España
- Sin especificar - Sin especificar
- 01/04/2024
- 30/06/2024
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