Sr Manager, Process Engineering
Core
Technical leader supporting clinical cell therapy manufacturing operations, ensuring reliable equipment and automation platforms for GMP production.
Role type
Senior Manager, Process Engineering & Automation
Builds
Clinical cell therapy manufacturing operations, automation platforms, and data-integrity compliant processes
Domain
Biopharmaceuticals / Cell Therapy / GMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
GMP manufacturing operations, automation systems, equipment lifecycle management, technology transfers, deviation investigations, change controls, data integrity, cross-functional collaboration, technical writing, team leadership
Preferred skills
Biologics/cell/gene therapy manufacturing, MES/EBR/SCADA/PLC/data historians, qualification and validation, AI-based solutions in manufacturing, mentoring staff
Technologies
MES, EBR, SCADA, PLC, data historians (OSI PI, Chronicle, CellFactory)
Responsibilities
Provide technical support for GMP manufacturing equipment and automation systems; Lead or support equipment troubleshooting and root-cause investigations; Support technology transfers and new product introductions; Author and review deviations, CAPAs, and change controls; Drive equipment improvements and implement data analytics tools; Lead and develop direct reports
Seniority
Senior Manager, hands-on IC with people leadership