Principal Engineer 35423

Principal Engineer to provide technical leadership across large-scale, non-routine engineering projects involving planning, design, modification, construction, maintenance, and optimization of systems, facilities, utilities, and manufacturing processes in a highly regulated environment. Lead cross-functional collaboration with Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, Validation, and Research to drive process characterization, optimization, scale-up, and continuous improvement. Establish and implement engineering policies, standards, and best practices; interpret and improve company-wide policies and procedures; develop and manage budgets for complex projects. Apply advanced engineering principles to solve operational and process challenges; lead investigations, define scope, evaluate alternatives, and develop innovative solutions; plan and conduct technical assessments of systems and processes. Coordinate and provide technical leadership to engineers, contractors, and technical personnel; define requirements and implement complex system, facility, or process modifications in collaboration with multiple teams. Serve as SME across multiple engineering disciplines; support GMP events, deviations, CAPAs, and continuous improvement initiatives; ensure compliance with GMP, GLP, safety, quality, and regulatory requirements. Perform duties and special projects as assigned. Preferred qualifications include experience with Clean Utilities, GMP and GLP practices, deviation investigations, CAPA management, process optimization, validation/qualification, technical documentation, risk assessments, and cross-functional leadership. Why Join: opportunity to lead high-impact projects and contribute to operational excellence in a world-class pharmaceutical/biotechnology manufacturing environment.