Immunitybio - El Segundo, CA
posted 4 months ago
As part of the Engineering Team, the Facilities Process Engineer II is responsible for maintaining, troubleshooting, and improving existing process equipment, overseeing the selection, procurement, and installation of new equipment, and assisting with projects to expand facilities in FDA regulated biopharmaceutical environments. This role requires close collaboration with facilities maintenance, GMP manufacturing, quality operations, leadership, and other functions to ensure successful ongoing manufacturing operations while also expanding those operations. The engineer will effectively interact and collaborate with cross-functional departments to meet company expectations and serve as a subject matter expert for assigned processes, equipment, and utilities. The Facilities Process Engineer II will manage small projects that require internal function oversight, developing project scope and timelines, and assist with multiple larger projects by representing engineering in a dynamic and changing environment. Responsibilities include identifying appropriate vendors and contractors, developing requests for proposals, managing the onboarding of new vendors, troubleshooting and coordinating investigations of manufacturing and laboratory processes, and leading teams to address deviations and non-conformances by performing root cause analysis. The engineer will also develop and implement preventive actions and corrective actions, author and review SOPs, protocols, and change controls, and mentor junior engineers or technicians on engineering policies and requirements to support GMPs. Additionally, the engineer will lead engineering design reviews as needed, collaborate with clients, contract manufacturers, and vendors to meet project and company objectives, and participate in audits and regulatory agency inspections as required. This position is critical in ensuring that the facilities and processes are compliant with regulatory standards and that the engineering team is well-equipped to handle the challenges of a biopharmaceutical environment.