Dinora Najera

Validation Engineer
Innovative technical expert, leveraging extensive experience of cGMP and regulatory requirements for manufacturing drugs, medical devices, and combination products with global business and regulatory exposures in dynamic environments. Meticulous with details and strong understanding of statistical analysis tools and methods to troubleshoot any problem, identify root cause, resolve issue, and follow through until successful closure. Collaborative style to lead and motivate cross-functional and cross-global teams, planning and coordinating projects, adapting to changes in priorities and schedules, setting vision and strategies to build and deliver results with integrity.
Global Change Management Global Validation & Quality Systems
Commissioning & Qualification Implementation Supplier Quality
Audit Processes Capital Engineering Project Support
Automated Process Controls Facilities & Utility Management
Equipment & Enterprise System Management Bilingual (English & Spanish)