Principal Process Engineer, Manufacturing Sciences & Technology, Cell Therapy

AstraZeneca seeks a Principal Process Engineer to lead manufacturing support for clinical and commercial cell therapy products at California facilities. The role oversees engineers while providing technical expertise in process execution, validation, technology transfer, and regulatory compliance.

Responsibilities

• Manage and mentor MS&T engineers; provide day-to-day technical support for cell therapy manufacturing campaigns
• Lead deviation investigations, root cause analysis, and CAPA implementation with appropriate documentation
• Maintain manufacturing data systems, perform trend analyses, and drive continuous improvements through change controls
• Support technology transfer activities, process validation, and PPQ execution with on-floor technical guidance
• Draft and review CMC documentation, SOPs, batch records, and regulatory submissions; ensure cGMP and ALCOA+ compliance

Requirements

• Hands-on expertise in cell therapy unit operations and processing equipment
• GMP environment experience including batch records, deviations, and investigations
• Statistical analysis proficiency including univariate, multivariate, and control charts
• Technical writing and verbal communication skills
• Data analysis and problem-solving abilities
• Cross-functional collaboration and team leadership experience