Principal Process Engineer, Manufacturing Sciences & Technology, Cell Therapy

We are seeking an experienced Principal Process Engineer to join our Manufacturing Sciences & Technology (MS&T) function as a member of the site-based MS&T team . This role will support multiple clinical manufacturing facilities at AstraZeneca’s Santa Monica, CA and Tarzana, CA locations. This position focuses on ensuring robust, compliant, and cost-effective manufacturing of clinical and commercial cell therapy pr oducts . This role will oversee a team of engineers, with individual contributions that may include: leading technical support, developing technical instructions , procedures , and operator training content , performing data analysis and process performance trending, leading complex deviation investigations, leading implementation of CAPAs and continuous improvement through change controls , and contributing to validation and regulatory deliverables . These responsibilities will be exercised through the scope of supporting , technology transfer, clinical manufacturing, site readiness, process validation/ PPQ, commercial manufacture readiness , and product lifecycle management activities. The ideal candidate brings hands-on experience with cell therapy unit operations through previous experience in process development and/or manufacturing, as well as expertise in technology transfer . Experience with process validation and commercialization activities is desired . This position will report to the Associate Director, MS&T, Cell Therapy Development and Operations . Key Responsibilities Site manufacturing support Manage, guide, and mentor MS&T engineer (s) Process Execution Support: Provide day-to-day technical support for cell therapy manufacturing , including managing on-the-floor support for critical campaigns (including occasional off-shift support where required ) Operations Support: Lead Site MS&T representation at operational tier meetings , pr oviding collaborative inputs that drive site activities Data trending and analysis : M aintain manufacturing data tracking system and control charts, perform trend analyses, identify signals, and drive timely signal-to-action with clear documentation and cross-functional alignment. Process performance monitoring: Conduct batch record review, deviation assessment, and data trending to ensure robustness of cell therapy manufacturing processes. Deviation/CAPA Support: Lead technical investigations for deviations and process excursions, perform root cause analysis, develop and implement CAPAs with appropriate data . Continuous improvements: Identify , justify, and implement continuous improvements by shepherding changes through cross ‑ functional change controls with appropriate risk assessments and comparability. Raw material s : Support qualification of critical materials (e.g., cytokines, viral vector, single-use assemblies) and assess impact of raw material changes, and contribute to second-source strategies Documentation & GMP Compliance: Author and revise batch records, SOPs, and technical reports; protocols, manufacturing summary reports, ensure adherence to cGMP/ATMP requirements and data integrity principles (ALCOA+). Training & Knowledge Transfer: Deliver operator training on critical process steps or process changes ; Develop and drive lessons-learned, playbooks, and best practices across sites. Regulatory Contributions: Draft and review CMC sections (Module 3), response to agency question , support health authority and internal audits/inspections. Technology Transfer & Process Validation Draft and review r isk assessments and comparability stud y design Establish framew