Senior Validation Engineer

Job description

Description: The Senior Validation Engineer is responsible for leading the installation, upgrade, and integration of manufacturing and packaging equipment within the sterile facility, ensuring all systems meet design specifications and operational requirements. This role will oversee and execute qualification activities, including FAT, SAT, IQ, OQ, and PQ while managing project timelines, budgets, and resources to ensure successful and timely completion of engineering initiatives. Essential Functions: - Lead manufacturing and packaging equipment installation/upgrades projects for sterile operations. Develop project scopes, technical plans, feasibility analysis, risk assessments, budgets, and execute aligned with business requirements. Coordinate activities related to procurement and contract management and manage maintenance activities by executing and tracking in accordance with organization SOPs. - Lead qualification activities, including factory acceptance test (FAT), site acceptance test (SAT), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for manufacturing and packaging equipment. Support to develop validation master plan,...