Biotechnology Equipment Specialist
4 weeks ago
**Job Summary:**
As a Biotechnology Equipment Specialist, you will be responsible for ensuring the equipment and systems required to support our expanding Cell Therapy facility are properly purchased, qualified, deployed, and maintained in accordance with GMP requirements.
**Key Responsibilities:**
* Lead the implementation of system/equipment changes from identification through implementation/release, including associated Change Controls.
* Develop and 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 manage equipment optimizations as well as system upgrades.
* Provide technical support for equipment/system related investigations and CAPAs.
* Ensure all equipment is maintained up to date, including the latest software, and have an understanding of next generation equipment and product roadmaps.
**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 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.
**About Legend Biotech US:**
Legend Biotech US is a global biotechnology company dedicated to treating and one day curing life-threatening diseases. 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.
**Equal Opportunity Employer:**
Legend Biotech US is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce.
**Drug-Free Workplace:**
Legend Biotech US maintains a drug-free workplace.
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