Principal Project Engineer for Drug Substance Equipment

About the role

This role is an integral part of our Equipment Engineering team, dedicated to supporting the delivery of high-quality biologics through the design and implementation of advanced upstream (USP) and downstream (DSP) process equipment. By joining this team, you will collaborate with global stakeholders, technical experts, and equipment manufacturers to lead complex capital projects and drive innovative solutions. Together, we aim to enable compliant and reliable drug substance manufacturing, ensuring life-saving medicines reach patients around the world.

Responsibilities

• Provide technical leadership and accountability for delivering complex engineering projects to support Roche's global manufacturing operations.
• Collaborate with diverse stakeholders and manage end-to-end project execution to ensure timely, quality-compliant, and cost-effective outcomes.
• Lead the planning, design, and implementation of biologics process equipment projects, ensuring adherence to Roche guidelines, industry standards, and regulatory requirements.
• Manage project budgets, schedules, risks, and resources while providing regular updates to ensure alignment with key stakeholders and project goals.
• Determine roles and responsibilities within multidisciplinary project teams and drive decision-making processes.
• Coordinate and conduct Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), equipment commissioning, and qualification activities to meet GMP compliance and operational readiness requirements.
• Serve as the technical interface with equipment manufacturers, overseeing design reviews, performance validation, and compliance management.
• Build and maintain strong working relationships with internal teams, external vendors, and engineering firms to ensure successful project execution.
• Provide mentorship and technical guidance to less experienced engineers, fostering skill development and team growth.

Requirements

• Bachelor's Degree in Chemical Engineering, Mechanical Engineering, or related discipline with 8+ years of experience, preferably in pharmaceutical biologics drug substance equipment, 6+ years of experience with a Master’s Degree.
• Experience managing international capital projects related to biologics drug substance equipment, with typical project budgets ranging from 15 to 50m CHF.
• Operational experience with biologics drug substance equipment (bioreactors, chromatography skids, filtration systems, centrifuges, laminar flow hoods, etc.).
• Experience with equipment manufacturer collaboration, FAT/SAT execution, and equipment commissioning/qualification activities.
• Demonstrated ability to execute highly complex scope on mid-sized to large-scale projects.
• Experience with regulatory compliance (FDA, EMA) and GMP requirements for biologics manufacturing operations.
• Project delivery experience in pharmaceutical manufacturing environments.
• Significant travel (50-60%) assignment requiring weekly commuting and/or temporary remote assignment as required to meet the business need (including on-site presence during FAT/SAT activities).
• International project assignment of 1 to 3 years as required to meet the business need.

Qualifications

• MS in Engineering (Chemical or Mechanical) and/or an MBA preferred.

Skills

• Strong technical skills in chemical and mechanical engineering.
• Excellent communication and interpersonal skills.
• Ability to work effectively in a fast-paced, dynamic environment.
• Proficiency in project management tools and methodologies.

Benefits

Details about benefits can be found here.

Pay

The expected salary range for this position based on the primary location of California is $109,900 - $204,100 USD Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

Schedule

This is an on-site position; no remote options are available at this time.

Equal Opportunity Employer

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.