Project Engineer (Biotech Focus)

Lead process and equipment troubleshooting to support deviations, corrective actions, and related issues while ensuring systems remain validated per FDA, EU, and Novo Nordisk requirements. Drive production-related projects and improvements for capacity optimization, including design and hazard reviews for plant expansions and serving as the technical point of contact for contractor services. Write and review protocols, summary reports, and trend documentation for ongoing production and verification activities. Initiate and manage projects by tracking budgets, creating scopes of work, and controlling payment schedules. Coordinate scheduling of improvement and critical production activities across areas and with external vendors, while regularly supervising contractor or intern reports. Participate in on-call rotations including weekends and non-business hours to provide support within sixty minutes.