Process Engineer Cell Therapy Jobs in California

Do you have a passion for IT, automation, and robotics? Would you like to join a winning team supporting the next generation of Cell Therapy manufacturing in one of the world's leading pharmaceutical companies? If you thrive in an environment of innovation and change in a fast-growing organization, then this could be the role for you.
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world's most serious diseases.
Introduction to Role
Join us at AstraZeneca, a place that champions knowledge-sharing, ambitious thinking, and innovation. We are looking for an integral member to join our Cell
Therapy Supply Chain - Robotics & Automation IT team. This role has a global remit and will play a critical part in delivering IT infrastructure, software integration, and cybersecurity capabilities for our robotic manufacturing platform.
The role focuses on enabling the deployment and sustained operation of robotic clusters within a GMP cell therapy manufacturing environment. You will be responsible for ensuring seamless IT/OT integration, supporting automation programming, managing vendor software platforms, and ensuring compliance with pharmaceutical cybersecurity standards. This position supports our strategic partnership with an external robotics vendor and directly contributes to patient-impacting manufacturing timelines.
Accountability
In this role, you will be responsible for delivering reliable IT and software engineering support across the full lifecycle of robotic cluster deployment-from Factory Acceptance Testing (FAT) through Site Acceptance Testing (SAT), installation qualification, operational qualification, and ongoing production operations. You will manage integration between robotic systems and enterprise platforms (MES, LIMS, ELN), implement cybersecurity controls aligned with DoD Zero Trust architecture and ISA-62443 standards, and collaborate cross-functionally with supply chain, quality, engineering, and external vendor teams.
You will serve as the primary technical interface between AstraZeneca IT and the robotics vendor's software and automation engineering teams, ensuring that platform readiness milestones are met and that all software licensing, data integrity, and system availability requirements are fulfilled.
Typical responsibilities

• IT/OT Integration & Architecture: Design and maintain robust OT/IT network segmentation, low-latency connectivity for real-time robotic control, and high-availability infrastructure targeting 99.99% uptime for production-critical automation systems.
• Cybersecurity & Compliance: Implement and enforce cybersecurity measures including Role-Based Access Control (RBAC), firewall segmentation, endpoint protection, patch management, SIEM integration, and audit logging in alignment with DoD Zero Trust Reference Architecture, ISA-62443, and FDA 21 CFR Part 11.
• Software & Automation Support: Support automation programming for robotic platforms, resolve software licensing issues, and coordinate with vendor engineering teams on software development lifecycle (SDLC) activities.
• System Integration: Ensure seamless integration of robotic clusters with Manufacturing Execution Systems (MES) such as PAS-X orTULIP, and with LIMS & ELN platforms to guarantee end-to-end traceability and electronic batch record compliance.
• Data Management & Traceability: Ensure all data acquisition systems support electronic records and electronic signatures per 21 CFR Part 11, maintain high-fidelity audit trails, and enable capture of process parameters, batch data, and material genealogy.
• IoT & Environmental Monitoring: Support IoT sensor integration for real-time environmental and equipment monitoring, configure automated alerting and escalation protocols, and maintain alarm management systems.
• Disaster Recovery & Business Continuity: Develop, test, and maintain disaster recovery plans for cloud-based and on-premise software/data systems; define and meet Recovery Time Objectives (RTO) and Recovery Point Objectives (RPO).
• Vendor Collaboration & FAT/SAT Support: Serve as the IT point of contact during FAT/SAT execution, support qualification activities, manage deviations and mitigation plans related to IT readiness, and ensure documentation alignment with project milestones.
• Cloud Platform Management: Support and manage cloud infrastructure associated with the robotic cluster platform (estimated at $2.5M annual cloud fee per cluster), ensuring security, cost efficiency, and performance.

Essential requirements

• Bachelor's degree in computer science, Software Engineering, Information Technology, or a related field (master's degree preferred).
• 5+ years experience in IT/OT environments supporting automation, robotics, or advanced manufacturing systems.
• Strong knowledge of cybersecurity frameworks including Zero Trust architecture, ISA-62443, and NIST standards.
• Demonstrated experience with MES platforms (e.g., PAS-X or TULIP), LIMS, and ELN systems integration.
• Proficiency in programming languages such as Python, C++, or C#, and familiarity with robotic frameworks (ROS, UR platforms, or similar).
• Working knowledge of FDA 21 CFR Part 11, GxP compliance requirements, and pharmaceutical data integrity principles.
• Experience with cloud platforms (AWS, Azure, or GCP) and IoT integration in manufacturing environments.
• Strong project management skills, including the ability to manage multiple concurrent workstreams, vendor timelines, and cross-functional dependencies.
• Excellent communication skills with the ability to translate complex technical topics for non-technical stakeholders.
• Comfort with risk and ambiguous situations in a rapidly evolving, first-of-its-kind program.

Desirable qualifications

• Experience working in advanced manufacturing systems and environments.
• Familiarity with ISPE GAMP 5 validation framework for computerized systems.
• Experience supporting FAT/SAT and IQ/OQ qualification activities.
• Knowledge of DevSecOps practices and Scaled Agile Framework (SAFe).
• Understanding of SEC cybersecurity disclosure requirements (17 CFR Parts 229, 232, 239, 240, 249).

The annual base pay for this position ranges from $122,985.60 - $184,478.40. 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.
When we put unexpected teams in the same room, we ignite ambitious 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, courage, curiosity, and collaboration fuel a relentless focus on transforming cancer outcomes, powered by a pipeline that fuses innovative science with advanced technology. You will work in an environment where unexpected teams come together to fuel bold ideas, backed by meaningful investment and a clear path from discovery to impact. We value kindness alongside ambition, and we empower leaders at every level to ask sharp questions, take smart risks, and turn data into decisions that help patients sooner.
Date Posted
30-Jun-2026
Closing Date
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.