Computer Systems Validation Specialist

Job description

Company Description 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. Job Description: 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 Accept...