Ll02-020924 Senior Automation Specialist For Medical Device Industry

LL02-020924 Sr. Automation Specialist (Medical Devices)Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:Senior Automation Specialist for Medical DevicesQualifications:Bachelor's Degree in Computer Science or Engineering.Minimum of 8 years of experience in direct pharmaceutical, medical device or biotechnology industries.Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays.Experience in Medical Devices, Automation Controls, Design Specifications, Allen Bradley, Software Validation and Design Review.Must be fully bilingual (English / Spanish) with excellent oral skills.Must be proficient using MS Windows and Microsoft Office applications.
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