Senior, IT GXP Systems Specialist

Benefits

Additional Information

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. 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 addresses, group policies, and user/group management security. Working knowledge of FDA cGMP and cGLP regulations including 21 CFR Part 11. Strong experience in customer service, incident management, and problem management. Strong technical, analytical, and business acumen with excellent attention to detail. Strong interpersonal and communication skills Strong troubleshooting and problem-solving skills, with the ability to learn and adapt to new technologies and processes quickly. Ability to manage multiple projects simultaneously while performing day-to-day activities. Ability to present technical information to management, employees, and other departments. Excellent interpersonal, written and verbal communication skills. Excellent ability to write, review, edit, and approve technical documentation. Ability to pivot and work well in complex, fast-paced environments. Strong leadership and influence skills with demonstrated business partnering approach. Proactive and self-motivated team player with exceptional organization, follow-through, time management, and communication skills. Proven ability to work collaboratively in a matrix organization. Working Environment / Physical Environment This position will be onsite. Regular work schedule is Monday - Friday, within standard business hours. Flexibility is a