MF01-111925 CQV Technical Support - SME

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: CQV Technical Support - SME Evaluate current manufacturing process control strategy. Develop qualification/validation strategy. Serve as SME to develop and execute qualification packages. Revise and approve qualification documents. Develop sampling plan to be executed during equipment qualification/validation activities. Lead/Facilitate Quality Risk Assessment (RA) Lead and/or participate on triage activities. Own change controls supporting the projects. Review and revise manufacturing instructions and SOPs as applicable to start-up of new equipment Qualifications: Bachelor's Degree in Science or Engineering. Minimum of 7 years of experience in direct pharmaceutical, medical device or biotechnology industries. Experience in direct process / manufacturing areas. Must be fully bilingual (English / Spanish) with excellent oral skills. SME in the Computer System Development Life Cycle (SDLC) Technical Writing skills and investigations processes. Available to work extended hours, possibility of weekends and holidays.