Staff Engineer, Project Engineering
Core
Manage and support capital projects up to $5MM to enhance manufacturing capabilities and ensure GMP compliance for pharmaceutical products.
Role type
Staff Engineer, Project Engineering
Builds
Manufacturing facilities and equipment for (pre)clinical and commercial pharmaceutical applications
Domain
Biopharmaceutical manufacturing
Required skills
Capital project management, GMP compliance, scope/schedule/budget tracking, quality record management, start-up and commissioning, risk assessment, feasibility studies, cross-functional collaboration, regulatory engagement, safety standards adherence
Preferred skills
Cleanroom experience, commissioning and validation in pharma settings, building codes knowledge
Technologies
Microsoft Project, AutoCAD, Bluebeam
Responsibilities
Manage contractors and capital projects up to $5MM; Develop and track scope, schedule, and budget; Initiate, manage, and close quality records; Lead start-up and commissioning activities; Author and review GMP documents; Conduct feasibility studies and prepare detailed project plans; Perform risk assessments and develop mitigation strategies; Engage with business leadership, customers, and regulators; Drive adherence to site safety standards
Seniority
Senior, hands-on IC
