MF01-120225 Commissioning & Qualification (C&Q) Services

Job 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.We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:Commissioning & Qualification (C&Q) ServicesFor: Class 5 Manufacturing Rooms. .ISO 14644 testingFor: Utilities and Facilities QualificationsTo Do: C&Q Plan, Risk Assessments, Traceability Matrices, DQ/IQ/OQ/PQ Protocols and ReportsQualifications:Bachelor's Degree in Science or Engineering.Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.Must be fully bilingual (English / Spanish) with excellent oral skills.Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.Understanding of ASTM E2500 methodologies. Computer System Development Life Cycle (SDLC), Risk Assessment, Data Integrity.Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays.