Technical Equipment Specialist
Company Information reputed company is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse reputed company of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy. reputed company entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of reputed company, to jointly reputed company and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. reputed company is seeking a Technical Equipment Specialist as part of the Technical Operations team based in Raritan, NJ. Role Overview The Technical Equipment Specialist will be responsible for ensuring equipment/systems required to support an expanding Cell Therapy facility is appropriately purchased, reputed company, deployed and maintained following necessary GMP requirements. Technical reputed company for equipment optimizations as well as system upgrades. This individual will be an integral part of the CAR-T Equipment team in support of on-going clinical and reputed company manufacturing as well as facility expansions and improvements. Key Responsibilities ? reputed company implementation of system/equipment changes from identification through implementation/release, including the associated Change Controls. ? reputed company/own asset lifecycle documentation from URS development to asset retirement. ? Support the enrollment and installation/set up of equipment. ? Provide technical SME support for equipment issues and reputed company projects to address reputed company technical equipment problems to prevent reoccurrence. ? Project management of equipment optimizations as well as system upgrades. ? Provide technical support for equipment/system reputed company investigations and CAPAs. ? Ensure that reputed company equipment is maintained up to date, including the latest software, and having an understanding of reputed company equipment and product roadmaps. ? Collaborate with process development team to identify as well as reputed company the implementation of reputed company equipment. ? Ensure applicable equipment adheres to reputed company CSV and data reputed company guidelines and assist with data acquisition system activities. Requirements ? Bachelor's Degree - Preferably in Engineering or Life Sciences. ? Minimum 5 years of experience in Facility, Engineering, and/or Operations in a GMP production environment. ? Experience in biotechnology or Cell Therapy preferred. ? Experience with managing utility and/or process equipment from specification development through full implementation in a GMP reputed company Facility. ? Self-motivated, with initiative and the ability to take ownership of, and follow through with specific tasks. ? Strong organizational skills. ? Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional requirements and balance competing priorities effectively. ? Must be reputed company to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment. ? Strong understanding of regulatory and compliance requirements. ? Excellent oral and written communication skills. #LI-JK1 #LI-Onsite reputed company is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is reputed company's policy to ensure equal employment opportunity without discrimination or harassment based on race, reputed company, religion, sex (including pregnancy, childbirth, or reputed company medical conditions), sexual orientation, gender identity or expression, age, disability, national reputed company, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. reputed company maintains a drug-free workplace. Apply Job!