Car-t Mfg. System Associate
il y a 1 semaine
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JOB DESCRIPTION:
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CAR T‐cells are an innovative approach to eradicate cancer cells by harnessing the power of a patient's own immune system.
By targeting BCMA via a CAR‐T approach, CAR‐T therapies may have the potential to redefine the treatment paradigm for multiple myeloma and potentially advance towards cures for patients with the disease.
Our brand-new Cell Therapy facility in Ghent (Belgium) is getting closer to start manufacturing and scalable operational flows need to be implemented to ensure we meet the highest quality standards without compromising manufacturing throughput.
This exciting new role works with the CAR-T Manufacturing Systems Lead and will be tasked with the design, plan, and implementation of multiple electronic Batch Records with the aspirational goal to become a paper-less manufacturing facility.
The position offers a perfect environment to understand Manufacturing Operations and all the underlying Supply Chain systems around it (Planning, Quality, Distribution, EHS ), something unique given the limited amount of Cell Therapy manufacturers worldwide.
The MES specialist should be passionate about Data and will get to work together with Janssen ́s Data Lake team to acquire business insights and propose data-driven solutions.
This is an outstanding opportunity to sit on an E2E Supply Chain team and develop critical thinking & business experience.
KEY RESPONSIBILITIES:
- Definition of Base Design for Master Batch Record and Recipe Structure
- Creation of Master Batch Records incl. MBR Modelling
- UAT Definition and Execution for System Validation
- Build and Review Documentation, Work Instructions
- Coordinate trainings for Operations and Operations Support
- Support System Integration (SAP, eLIMS, Data Lake, OSI PI )
- Serve as SME to support various projects/initiatives requiring Manufacturing data
Qualifications:
**=== QUALIFICATIONS ===
EDUCATION:
- Bachelor's or Master's Degree In Engineering, Information Technology, Industrial Automation Or Equivalent
- Preferably 13 Years of Experience with electronic Manufacturing Processes (GxP) And Related Master Data Management
EXPERIENCE AND SKILLS:
- High Affinity for New Technologies and Manufacturing Processes
- Teammate who loves to combine Continuous Improvement with respect to Safety, Quality, Reliability/Speed, Cost Awareness, and People Development
- Excellent Written and Oral Communication Skills
- Exposure to other supply chain systems (SAP, eLIMS, PAS-X MES, OMP, OSI PI, Tableau )
OTHER:
- Proficiency in Dutch and English
- Location: Ghent, Belgium
- Travel: mínimal (5%)
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