Gent, BEL
3 days ago
Sr Process Engineer (Hybrid - Gent)
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Supply Chain Engineering **Job Sub** **Function:** Process Engineering **Job Category:** Scientific/Technology **All Job Posting Locations:** BE022 GENT **Job Description:** CAR-T is an innovative treatment, which uses the power of the patient’s own immune system. 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 Process Engineer is part of the Manufacturing Science and Technology (MSAT) team. You will have the unique opportunity to gain deep knowledge & expertise in a highly innovative and future oriented environment with the ability to profoundly impact the trajectory of health of our patients. **Key responsibilities** As process engineer you will immerse yourself in CAR-T processes and build up solid expertise. You will support the strategic plan by designing and implementing Process Validation / Engineering activities and provide scientific knowledge and cGMP expertise in cell and gene therapy processes and process technologies to establish the appropriate holistic Process Control Strategy As process engineer you will be responsible to: + Ensure process robustness by owning the process knowledge of the cell and gene therapy manufacturing process technology and providing scientific and technical expertise + Design studies necessary to successfully implement/validate the manufacturing process + Support and ensure cGMP readiness of the product process through an appropriate validation strategy in compliance with regulations, procedures and the validation master plan + Serve as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits + Provide scientific support + Identify opportunities for continuous process improvements/operational excellence. Partner with all relevant teams and/or external vendors to implement process improvements **Experience** + You have a Master’s Degree in a scientific or technical field (Engineering, Science or related field) or equivalent experience + Minimum 5 years of relevant work experience in the biotech/biopharma industry. + Cell and Gene Therapy manufacturing experience preferred. **Skills** + You have a start-up/can-do mindset, and you proactively search for solutions + **Your verbal and written communication skills enable you to influence without authority** + You have strong analytical, problem solving and critical thinking skills + 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 **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
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