Principal Project Engineer Packaging & Device Assembly (US)

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

The Position

This role is an integral part of our Equipment Engineering team, dedicated to delivering cutting-edge solutions for Device Assembly and Finished Goods Packaging systems that ensure safe, efficient, and compliant pharmaceutical manufacturing. As a member of this team, you will collaborate with global stakeholders, equipment manufacturers, and multidisciplinary project teams to drive the successful delivery of capital projects. With a focus on innovation, quality, and operational excellence, you will contribute to advancing Roche’s mission of providing life-changing medicines to patients worldwide.

The Opportunity

As a Principal Project Engineer Packaging & Device Assembly (US), you will lead and manage the technical execution of equipment sub-projects, driving collaboration across global teams and ensuring compliance with industry standards. You will be accountable for delivering innovative, high-quality solutions that support the manufacturing of Roche’s life-saving medicines.

Additionally, you will:

• Independently plan, design, and implement mechanical and process engineering projects, ensuring full compliance with Roche Guidelines, Global Standards, and Health Authority Requirements.
• Manage the approved sub-project budget and schedule, define priorities, and provide regular updates on progress, risks, mitigation strategies, and escalations.
• Serve as the primary interface with equipment manufacturers, managing technical specifications, design reviews, performance validation, and compliance requirements.
• Drive mechanical and automation engineering for state-of-the-art assembly systems for pre-filled syringes, autoinjectors, and pen injectors in compliance with relevant standards and regulations
• Lead and coordinate Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), commissioning, and qualification activities to ensure operational readiness of equipment.
• Direct and manage external engineering firms, service providers, and contractors to ensure timely and quality-compliant project execution.
• Guide overall project scope, including options analysis, project planning, detailed scheduling, and resource allocation.
• Mentor and coach less experienced engineers, fostering technical growth and professional development across the team.
• Act as a technical Subject Matter Expert (SME) for manufacturing equipment and machine safety during regulatory inspections and audits.

Who You Are

• You possess a Bachelor’s Degree in Mechanical Engineering, Chemical Engineering, or a related discipline with 8+ of experience, or a Master’s Degree with 6+ years of experience in device assembly or finished goods packaging equipment; an MS in Engineering and/or an MBA is preferred.
• You possess extensive years of experience in international management of capital projects related to device assembly and finished goods packaging, with typical project budgets ranging from 18 to 60 M USD.
• You have proven experience collaborating with equipment manufacturers, leading FAT/SAT efforts, and managing equipment commissioning and qualification activities.
• You possess significant knowledge of regulatory (FDA, EMA) and GMP requirements, as well as machine directives and relevant standards for combination products with demonstrated success in delivering complex projects in pharmaceutical manufacturing environments.
• Significant travel (50% +) assignment requiring weekly commuting and/ or temporary remote assignment as required to meet the business need (including on-site presence). International project assignment of 1 to 3 years as required to meet the business need.

Relocation benefits are not available for this posting.

The expected salary range for this position based on the primary location of OR, is $109,900 to $204,100. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.