MES Engineer

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: Senior Computer System Validation (CSV) Specialist - with expertise in Manufacturing Execution Systems (MES), specifically Syncade , to support a biologics manufacturing facility. The role will be responsible for planning, authoring, executing, and reviewing validation deliverables in compliance with FDA, EMA, ICH, and GAMP 5 guidelines. The candidate will work closely with Quality, IT, Engineering, and Manufacturing teams to ensure validated, compliant, and reliable MES system operation throughout the system life cycle. Key Responsibilities: - Lead and execute CSV activities for MES (Syncade) in a biologics GMP environment. - Develop and maintain validation documentation including Validation Plans, User Requirements (URS), Functional Specifications (FS), Design Specifications (DS), Risk Assessments, IQ/OQ/PQ protocols, and summary reports. - P...