Principal Project Engineer Packaging & Device Assembly (US)
Core
Lead technical execution of capital projects for device assembly and finished goods packaging systems in pharmaceutical manufacturing.
Role type
Principal Project Engineer (Mechanical/Process)
Builds
State-of-the-art assembly systems for pre-filled syringes, autoinjectors, and pen injectors
Domain
Pharmaceutical manufacturing / Medical device assembly
Required skills
Mechanical engineering, Project management, Equipment commissioning, Regulatory compliance (FDA/GMP), Vendor management, Budget management, Technical mentoring, FAT/SAT leadership, Machine safety expertise
Preferred skills
Master's degree in Engineering, MBA, International project management experience
Technologies
None explicitly listed
Responsibilities
Plan, design, and implement mechanical and process engineering projects; Manage project budget and schedule; Serve as primary interface with equipment manufacturers; Drive mechanical and automation engineering for assembly systems; Lead FATs, SATs, commissioning, and qualification; Direct external engineering firms and contractors; Guide overall project scope and resource allocation; Mentor less experienced engineers; Act as SME for regulatory inspections
Seniority
Principal, hands-on IC with mentorship responsibilities