Manufacturing Application Engineer – Digital Manufacturing & Automation, Cell Therapy

AstraZeneca • Los Angeles, CA

22h • Hybrid

About The Position

This role is responsible for architecting the digital backbone of Cell Therapy manufacturing and accelerating life-changing treatments to patients. The individual 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 global Cell Therapy operations while governing delivery through external partners. The role connects Manufacturing Operations, Automation Engineering, Digital, Quality, and Product teams to deliver scalable, compliant, and intelligent manufacturing ecosystems. This includes custom-built LIMS applications, MES, robotics integration, Tulip applications, and end-to-end process orchestration, transforming 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.

Requirements

• 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

Nice To Haves

• 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

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Benefits

• Qualified retirement programs
• Paid time off (i.e., vacation, holiday, and leaves)
• Health, dental, and vision coverage
• Eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles

What This Job Offers

• Job Type: Full-time
• Career Level: Senior