Manufacturing Application Engineer – Digital Manufacturing & Automation, Cell Therapy

Role: Lead digital manufacturing systems architect for Cell Therapy operations, owning product vision and governance of platforms including LIMS, MES, robotics, and automation integration. Responsibilities: define requirements, oversee vendor solutions, ensure compliance with GxP/regulatory standards, govern technical designs, and manage delivery roadmaps for scalable, compliant manufacturing ecosystems. Focus on internal ownership, reducing external dependencies, and building global standards. Collaborate across Manufacturing Operations, Automation, Digital, Quality, and Product teams, translating operational needs into technical solutions. Manage AI/ML applications, process orchestration, and Industry 4.0 initiatives. Requirements: Bachelor's in Computer Science, Engineering, or related; 8+ years in manufacturing systems, automation, or digital platforms within regulated environments; experience managing external vendors, with strong technical skills in APIs, middleware (HighByte, OPC-UA), automation integration, and data management; deep understanding of GxP, CFR Part 11, validation. Preferred: experience in Cell Therapy, biologics, Tulip or similar low-code platforms, robotics, AI/ML in manufacturing, cloud-native development, and related standards (ISA-95, ISA-88). Work setup: in-person in Tarzana, CA, with flexible balance; no travel specified.