Global Project Engineer: Packaging & Device Assembly

F. Hoffmann-La Roche AG; Hillsboro (OR); On-site; USD 110,000 - 204,000; Full time

Benefits offered by this job

Discretionary bonus

Job summary

Genentech, a Roche subsidiary, seeks a Principal Project Engineer Packaging & Device Assembly (US) to lead technical execution of equipment sub-projects across global teams. You will drive design, validation, and compliance for assembly systems used in pre-filled syringes, autoinjectors, and pens, ensuring readiness and regulatory alignment.

You will manage budgets, schedules, FAT/SAT activities, and coordinate external partners while mentoring junior engineers and ensuring adherence to FDA/EMA

Qualifications

• Bachelor’s degree in Mechanical or Chemical Engineering with 8+ years of experience, or Master’s with 6+ years.
• Experience in device assembly and finished goods packaging equipment.
• Extensive experience in international capital projects management and budgets.
• Proven track record with FAT/SAT, equipment commissioning and qualification.

Responsibilities

• Independently plan, design, and implement mechanical and process projects in packaging and device assembly.
• Manage budgets/schedules; provide progress updates, risks, and mitigations.
• Interface with equipment manufacturers; manage specs, reviews, and compliance.
• Lead FAT/SAT, commissioning, and qualification activities to ensure readiness.
• Guide project scope, planning, scheduling, and resource allocation; mentor engineers.
• Serve as SME for manufacturing equipment and machine safety during regulatory inspections.

Skills

Project leadership

Equipment design

Regulatory compliance

Cross-functional collaboration

Global project management

Education

Bachelor's in Mechanical or Chemical Engineering

Master's degree (preferred)

Job description

Genentech, a Roche subsidiary, seeks a Principal Project Engineer Packaging & Device Assembly (US) to lead technical execution of equipment sub-projects across global teams. You will drive design, validation, and compliance for assembly systems used in pre-filled syringes, autoinjectors, and pens, ensuring readiness and regulatory alignment.

You will manage budgets, schedules, FAT/SAT activities, and coordinate external partners while mentoring junior engineers and ensuring adherence to FDA/EMA