MF03-050324 Process Development Engineer / Manufacturing Engineer

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: Process Development Engineer / Manufacturing Engineer Responsibilities: Manage process development projects from conception to implementation. Experience with design of experiments (DOE) to characterize and optimize processes. Develop PFMEA methodology for risk analysis. Identify areas of improvement in processes and develop strategies to optimize it. Support process and/or equipment validation activities (IQ, OQ, PQ); process performance qualification activities and develop Master validation plans for new processes or products. Qualifications: Bachelor's Degree in Science or Engineering. Minimum of 5 years of experience in direct pharmaceutical, medical device (preferable) 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. Technical Writing skills and investigations processes. Available to work extended hours, possibility of weekends and holidays.