Project Engineer-Csv-Validation-Equipment-Agile

Descripción del Empleo:
Trains production personnel, and other engineers/technicians. Identifies need and develops manufacturing documentation following, standards and regulations established by regulatory agencies. Leads and / or participates in development, qualification and validation activities for product or technology transfers on automated equipment’s. Collaborates with technical experts, design, and other facilities for the process development of new devices. Supports equipment development efforts for new devices, and process improvements. These efforts may be the internal development of process equipment or coordination with an external equipment integration company. Ensures compliance with company policies, programs, procedures, regarding to government and regulatory agencies regulations (e.g. EEO, ADA, ISO, QSR). Performs other related duties as required.
Requisitos:
Minimum 3 years of experience working in regulated industry. Knowledge and experience validating automated manufacturing equipment. Knowledge and experience on Computerized System Validation Cycle (CSV). Experience working with Agile. Exposure to Manufacturing Environment Bachelor’s degree in Engineering Completed. Fully Bilingual. Immediately Availability. Qualified candidates please send your resume to **********