Senior Project Engineer – Packaging & Device Assembly

Genentech; Hillsboro (OR); On-site; USD 110,000 - 204,000; Full time

Job summary

Genentech is seeking a Principal Project Engineer Packaging & Device Assembly to lead technical execution of equipment sub-projects for parenteral device assembly and finished goods packaging. You will collaborate with global teams, manage budgets, schedules, and work with manufacturers to ensure specification compliance and validation.

The role requires 8+ years in device assembly or packaging equipment, with international project experience and familiarity with FDA/EMA GMP standards.

Qualifications

• Bachelor’s or Master’s degree in a relevant engineering field with significant experience in device assembly or finished goods packaging equipment.
• Experience managing international capital projects with multi-million USD budgets.
• Proven track record delivering FAT/SAT, commissioning, and qualification activities.
• Strong knowledge of FDA/EMA regulatory requirements and GMP for pharmaceutical manufacturing.

Responsibilities

• Lead technical execution of equipment sub-projects across global teams.
• Manage budgets, schedules, priorities, and risk mitigation for capital projects.
• Interface with equipment manufacturers on specs, design reviews, and validation.
• Drive mechanical and automation engineering for assembly systems for injectable devices.
• Lead FATs, SATs, commissioning, and qualification activities to ensure readiness.
• Coordinate external engineering firms and contractors for timely, quality project delivery.

Skills

Project management

Global stakeholder coordination

Regulatory compliance

Capital project management

Education

Bachelor’s Degree in Mechanical or Chemical Engineering or related

Master’s Degree in Engineering and/or MBA

Tools

FAT/SAT coordination tools

Automation & equipment commissioning

Job description

Genentech is seeking a Principal Project Engineer Packaging & Device Assembly to lead technical execution of equipment sub-projects for parenteral device assembly and finished goods packaging. You will collaborate with global teams, manage budgets, schedules, and work with manufacturers to ensure specification compliance and validation.

The role requires 8+ years in device assembly or packaging equipment, with international project experience and familiarity with FDA/EMA GMP standards.