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Leads manufacturing engineering operations, technical projects, process improvement, and validation activities. Provides mentorship to associate engineers and COOP students, develops and executes IQ/OQ/PQ protocols, applies statistical analysis, resolves complex manufacturing challenges, and ensures GMP, quality, and compliance standards are met while improving operational efficiency.

Lead automation projects for design, implementation, testing, commissioning, validation support, and closeout in a GMP-regulated manufacturing environment. Coordinate system integration, PLC and BMS/Zenon/EMS modifications and migrations, manage schedules, risks, outages, and stakeholder/vendor coordination while ensuring compliance with safety, quality, and site procedures.

Lead end-to-end project delivery in a structured PMO environment, managing scope, schedules, budgets, risks, dependencies, change control, governance, documentation, and KPI reporting. Coordinate cross-functional teams in matrixed organizations, resolve roadblocks, maintain stakeholder alignment, and improve project delivery processes using standardized methodologies and tools.

Coordinate and manage engineering drawing revisions, approvals, and documentation control within regulated pharmaceutical/biotech capital projects. Support CAD drafting, maintain archives per site procedures, ensure compliance with drawing management systems, and liaise with site personnel, project teams, and clients to meet dynamic project schedules.

Leads onsite engineering activities at an FDA-regulated manufacturing facility, coordinating CQV, automation, process, facilities, maintenance, quality, and operations teams. Drives project execution, schedules, technical issue resolution, equipment installation and startup, qualification, troubleshooting, upgrades, and continuous improvement. Ensures compliance with GMP, safety, quality, and site requirements while communicating priorities, risks, and project status to stakeholders.