Senior, IT GXP Systems Specialist at ImmunityBio in El Segundo Mariposa, CA

Job description

Company Overview ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases. • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California. • Work with a collaborative team with the ability to work across different areas of the company. • Ability to join a growing company with professional development opportunities. Position Summary The Senior IT GxP Systems Specialist position will manage day-to-day system administration, user support and implementation of GxP computerized systems for laboratories, manufacturing and other regulatory operations. In close partnership with R&D, Quality Control, Engineering and Manufacturing functional leads, the position will provide technical leadership for new system deployments, upgrades, and maintenance of GxP systems including networked and non-networked stand-alone equipment at multiple ImmunityBio sites. Essential Functions Responsible for implementing and maintaining software supporting GxP laboratory equipment. Responsible for daily GxP system operations, maintenance, and support. Create and maintain system documentation, specifications, IT administrative and security SOPs and execute test scripts related to GxP systems to support Computer System Validation Systems Validation (CSV). Follow IT and Quality processes to maintain systems in a validated state and ensure GxP systems are in compliance with 21 CFR part 11. Manage incident tickets, perform troubleshooting and periodic assessments of systems. Evaluate and assign appropriate data security, user roles and privileges for data integrity. Coordinate with system vendors and business partners in various functions to schedule upgrades, maintenance, and support activities. Flexibility to provide 24 x 7 IT support for operations. Create and maintain service catalog related to IT GxP operations. Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs. Education & Experience Bachelor’s degree in Information Technology, Computer Science, Engineering, or a related field with 4+ years of hands-on Systems Administration experience supporting end-users, servers, applications, storage, and networking in a pharmaceutical or related industry is required; OR High School Diploma or equivalent with 8+ years of hands-on Systems Administration experience supporting end-users, servers, applications, storage, and networking in a pharmaceutical or related industry is required. 1+ years of providing IT support in a GxP environment is preferred. Knowledge, Skills, & Abilities Strong understanding of Windows operating systems, networking protocols (TCP/IP, DNS, DHCP), VLANs, wireless access points, IP ad