Manufacturing Application Engineer – Digital Manufacturing & Automation, Cell Therapy

Job description

### **Location:** Tarzana, CA 91356, United States of America # Introduction to role: Are you ready to architect the digital backbone of Cell Therapy manufacturing and see your work accelerate life-changing treatments to patients? In this role, you will be the internal authority on what gets built, how it's built, and why — owning the product vision for next-generation digital platforms that power our global Cell Therapy operations while governing delivery through external partners. You will connect Manufacturing Operations, Automation Engineering, Digital, Quality, and Product teams to deliver scalable, compliant, and intelligent manufacturing ecosystems. From custom-built LIMS applications and MES to robotics integration, Tulip applications, and end-to-end process orchestration, you will turn complex GMP workflows into simple, reliable digital experiences that reduce cycle time, increase reliability, and protect chain of identity and custody. This is a strategic individual contributor role focused on building internal digital manufacturing expertise, reducing dependence on external integrators, and ensuring AstraZeneca retains full intellectual ownership of its manufacturing platforms. # Accountabilities: - **Delivery Partner Governance & Product Ownership:** Serve as the internal technical product owner across digital manufacturing workstreams; define what gets built and hold external delivery partners accountable to quality, compliance, and architectural standards. Review and challenge vendor technical designs, ensure AstraZeneca retains full knowledge and ownership of delivered solutions, and prevent dependency on any single integrator. Map and own the product roadmap from day one, gathering requirements from stakeholders and translating operational needs into a coherent, prioritized delivery plan. - **Custom LIMS Applications & Digital Manufacturing Platforms:** Own the delivery of custom-built LIMS applications and scalable digital manufacturing platforms across Cell Therapy operations. Define requirements for MES, LIMS, automation interfaces, robotics workflows, and orchestration capabilities that enable digital batch execution, electronic work instructions, device integration, and real-time visibility. Ensure delivery partners build to specification and compliance standards. - **MES & LIMS Workflow Orchestration:** Define and govern orchestration frameworks that integrate MES, LIMS, ERP, automation systems, robotics, and data platforms for autologous and allogeneic processes. Specify process flows, APIs, data exchange patterns, and event-driven architectures. Validate vendor-delivered implementations against technical and compliance requirements. - **Tulip Manufacturing Applications:** Own the Tulip application roadmap and delivery; define requirements, user stories, and acceptance criteria. Oversee development of reusable components, connectors, and low-code workflows that streamline operator execution, deviations, equipment monitoring, and process visibility. Partner with manufacturing SMEs to prioritize and validate solutions. - **Robotics & Manufacturing Automation Integration:** Ensure successful integration of robotics platforms, automation equipment, OT systems, and edge devices by defining requirements, validating technical designs, and holding delivery partners to implementation quality standards. Technical fluency in middleware (HighByte, OPC-UA), industrial connectivity, and file system management is required to credibly govern this work and identify when vendor approaches create unnecessary risk or dependency. - **Enterprise Systems Integration:** Define integration requirements between MES, LIMS, SAP, automation, and analytics platforms to enable real-time sample tracking, chain of identity/custody, and manufacturing genealogy. Own canonical data models and govern API integrations with ERP, vein-to-vein systems, and custom supplier applications. - **Technical Leadership & Solution Delivery:** Act as technical product owner, managing roadmaps, sprints, and stakeholder expectations. Apply Agile, CI/CD, DevSecOps, automated testing, and version control principles to ensure delivered solutions are scalable, secure, maintainable, and GxP-compliant. Review and validate all partner and vendor technical deliverables. - **AI & Advanced Digital Manufacturing:** Leverage AI/ML for workflow optimization, exception handling, predictive maintenance, and manufacturing intelligence. Support digital twins, analytics, and intelligent automation through rapid experimentation and Industry 4.0 adoption. - **Cross-Functional Collaboration & Scale:** Translate business needs into delivery plans; support deployments, validation, training, and operational readiness. Establish global standards and reusable templates that accelerate scale across sites and reduce dependence on external integrators. # Essential Skills/Experience: - Bachelor's degree in Computer Science, Engineering, Automation Engineering, Information Systems, Electrical Engineering, or related field - 8+ years of experience in manufacturing systems, digital manufacturing, MES/LIMS implementation, or automation engineering - Strong technical product ownership or program management experience leading complex manufacturing system implementations through internal teams and/or external delivery partners - Experience with MES/LIMS platforms in pharmaceutical, biotech, cell therapy, or regulated manufacturing - Proven experience managing and governing external vendors, system integrators, or delivery partners — including reviewing technical designs, challenging architectural decisions, and validating implementation quality - Experience integrating manufacturing automation systems, robotics, environmental monitoring, and OT systems - Hands-on technical background across the following domains, applied in this role to define requirements, evaluate vendor designs, and validate delivery quality: - API development and integration - Middleware platforms (HighByte, OPC-UA, MQTT) - File system management (SMB, NFS) and scripting - Database design and connectivity - Event-driven architectures - Experience with SAP manufacturing integrations - Strong understanding of GxP, CFR Part 11, data integrity, and validation requirements - Experience in Agile product delivery environments # # Desirable Skills/Experience: - Experience in Cell Therapy, Gene Therapy, biologics, or ATMPs - Experience with Tulip platform or similar low-code manufacturing platforms - Experience with manufacturing orchestration platforms and digital thread architectures - Experience with HighByte, OPC-UA, MQTT, or industrial connectivity platforms - Experience integrating robotics platforms and autonomous manufacturing systems - Exposure to AI/ML applications in manufacturing operations - Experience designing manufacturing data platforms and operational analytics solutions - Knowledge of ISA-95, ISA-88, and Industry 4.0 principles - Programming experience with Python, JavaScript, Java, C#, or similar - Experience with cloud-native applications and CI/CD pipelines - Previous experience at a system integrator, consultancy, or delivery partner serving regulated industries When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. ## Why AstraZeneca: Here, technology and science meet to transform how medicines are made and delivered to patients. You will join a diverse, international network that brings together unexpected combinations of expertise to solve tough problems, move quickly, and build at scale. We invest for impact, pairing leading digital platforms with data and AI in a modern environment where you can experiment, take ownership, and see your work ripple across sites and therapies. We value kindness alongside ambition, encourage learning through hands-on innovation, and back you with the partnerships and resources to design systems that disrupt the industry and make a measurable difference for patients. ## The annual base pay for this position ranges from $127,352 to $191,028. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. Shape the digital engine of Cell Therapy manufacturing—apply your expertise today to own intelligent, compliant systems that scale globally and accelerate treatments to patients. ## **Date Posted** 02-sept-2026 **Closing Date** 29-sept-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.