- Lead implementation of system/equipment changes from identification through implementation/release, including the associated Change Controls.
- Develop/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 lead projects to address complex technical equipment problems to prevent reoccurrence.
- Project management of equipment optimizations as well as system upgrades.
- Provide technical support for equipment/system related investigations and CAPAs.
- Ensure that all equipment is maintained up to date, including the latest software, and having an understanding of next generation equipment and product roadmaps.
- Collaborate with process development team to identify as well as lead the implementation of next generation equipment.
- Ensure applicable equipment adheres to all CSV and data integrity guidelines and assist with data acquisition system activities.
- 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 Commercial 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 able 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.
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Technical Equipment Specialist - Raritan, United States - Legend Biotech US
Description
Company InformationLegend Biotech 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 array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop 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.
Legend Biotech 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, qualified, deployed and maintained following necessary GMP requirements. Technical lead 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 commercial manufacturing as well as facility expansions and improvements.
Key Responsibilities
Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
Legend Biotech maintains a drug-free workplace.
