Manager, Engineering - Capex Projects

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 Manager, Engineering- Capex Projects is responsible for providing leadership for overseeing the planning, execution, and delivery of capital construction projects within Good Manufacturing Practice (GMP) regulated environments. This individual serves as the primary technical authority and project owner for commercial construction initiatives, ensuring all projects meet regulatory compliance, engineering standards, cost targets, and schedule milestones. The role requires close collaboration with facilities maintenance, project management, manufacturing operations, quality operations, site leadership, contractors and other functions to ensure successful ongoing manufacturing operations, while also expanding those operations. Essential Functions Lead Major Capex projects from concept design, RFP, buildout, commissioning, and handover to users. Includes project plans, budgets, schedule, and vendor management Manage Contractors and Engineers to ensure designs/equipment are installed to ImmunityBio standards Develop and maintain project charters, scope statements, execution plans, budgets, and master schedules across multiple simultaneous capital initiatives. Provide technical oversight of civil, structural, mechanical, electrical, plumbing, HVAC, and process piping systems within GMP facilities, including cleanrooms, HVAC cascade design, CIP/SIP systems, and utility distribution. Commercial Manufacturing Facility and Lab Development/Design Review and Approve engineering deliverables including equipment submittals, P&IDs, and equipment layouts prior to installation and commissioning Ensure designs, material, personnel, process, and product flows comply with latest Global cGMP requirements Develop and execute commissioning plan as part of the facility lifecycle prior to validation activities Coordinate all construction activities with the internal departments to ensure no interruptions to ongoing processes Collaborate effectively with cross-functional departments in order to meet company expectations. Mentor, coach, train engineers on engineering practices, policies and requirements to support GMP operations. Troubleshoot and coordinate investigations of manufacturing and laboratory processes when needed. Assist with vendor communications and maintenance/repair scheduling by placing work orders Collaborate with clients, contract manufacturers, and vendors to meet project and company objectives. Lead engineering design reviews as needed. Participate in audits and regulatory agency inspections, as needed. Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates. Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities Education & Experience Bachelor's degree in engineering or a related field with 5+ years of relevant experience is required. 3+ years of experience with Capex project is required. Experience and ability to effectively support operations in a GMP manufacturing environment is required. Experience and ability to provide engineering leadership for both small projects and expansion capital projects is required. Experience with equipment/process troubleshooting and repair is required. Experience with facility and equipment commissioning and validation is required. Experience working with a Pharmaceutical or Biotechnology organization is preferred. Must possess and maintenance of a current valid driver's license is required Knowledge, Skills, & Abilities Knowledge of engineering principles required to support GMP facilities and equipmen