Validation Engineer III

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 SUMMARYThe Validation Engineer III is responsible for coordinating all validation activities by constant communication with affected departments and personnel; oversees and reviews validation area processes and procedures. Prepares all protocols, executing of protocols and reports for validation work in a FDA regulated biopharmaceutical environments. The Validation Engineer III reports to a manager or head of a unit/department. The Validation Engineer III contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature. This includes oversight of contractors as we supplement validation staff during expansion activities.ESSENTIAL FUNCTIONS * Lead interaction and collaboration with cross-functional departments in order to meet company expectations * Lead and perform validation activities for equipment, utility systems, facilities, processes, and automation systems in compliance with approved SOPs, cGMPs, and applicable regulatory requirements, * Generate and execute validation protocols (IQ/OQ/PQ/CV/PV) of all site equipment including laboratory equipment, production equipment, utilities (as applicable) and other related systems in an FDA regulated environment, * Author and review SOPs, protocols, reports, and validation master plans for GMP equipment, instruments, and computerized systems, * Generate and keep current inventory of GMP systems and requalification/revalidation schedules, * Perform risk assessments for GMP systems as required, * Plan validation efforts according to risk, * Collaborate with clients, CMO's, and vendors to meet project and company objectives, * Own the communications process with vendors * Troubleshoot and resolve discrepancies reported during validation/qualification * Troubleshoot, coordinate, and resolve failure investigations for manufacturing and laboratory equipment, * Provide technical input to assist in development of project planning, * Provide technical project management deliverables for certain phases of a project including but not limited to scheduling, design, estimates, engineering specifications, drawings, materials procurement, construction contracts, cost tracking and project cost projections. * Partner with engineering studies and investigation studie