Computer Systems Validation Specialist

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: - CSV Validation Specialist (Lab equipment)  Qualifications: - Bachelor's Degree in Science or Engineering. - Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries. - Experience in direct process / laboratory areas. - Must be fully bilingual (English / Spanish) with excellent oral skills. - Must be proficient using MS Windows and Microsoft Office applications. - 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, CSV protocols development and execution, deviations and reports generation. - SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT). - Strong knowledge of Ellab Data Loggers, Star Oddi Sensors, Keyence Microscopes, Kaye Data Loggers, X-Ray, Bar Code Verifiers. - Experience with Kneat, CDOCS, Maximo. - Technical Writing skills and investigations processes. - Available to work extended hours, possibility of weekends and holidays. All your information will be kept confidential according to EEO guidelines.