Principal Project Engineer for Single-Use Equipment

F. Hoffmann-La Roche AG; Oceanside (CA); On-site; USD 109,900 - 204,100; Full time

Job summary

F. Hoffmann-La Roche AG is seeking a Principal Project Engineer for Single-Use Equipment in Oceanside, California. This role entails leading engineering projects for biologics manufacturing, ensuring compliance with industry standards, and driving collaboration across global stakeholders.

The ideal candidate holds a Bachelor’s Degree and has over 8 years of experience in biologics process equipment, with expertise in managing international projects. The expected salary range is $109,900 – $204,100 annually, with benefits available.

Qualifications

• 8+ years of experience in pharmaceutical biologics equipment.
• Experience managing international capital projects with budgets from 15 to 50mCHF.
• Operational experience with bioreactors, chromatography skids, and filtration systems.

Responsibilities

• Lead the planning and execution of engineering projects.
• Manage budgets, schedules, and resources for timely project delivery.
• Serve as primary interface with equipment suppliers for design reviews.

Skills

Project management

Collaboration with equipment manufacturers

GMP compliance

Biologics process equipment

Education

Bachelor’s Degree in Chemical Engineering, Mechanical Engineering, or related discipline

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

Job description

Opportunity

This role is a key part of our Equipment Engineering team, dedicated to delivering cutting‑edge solutions for Single‑use Systems in biologics manufacturing. As a Principal Project Engineer for Single‑Use Equipment, you will serve as a technical leader responsible for managing and delivering engineering projects focused on biologics process equipment, ensuring compliance with industry standards, regulatory requirements, and Roche guidelines. You will drive collaboration across disciplines and global stakeholders to achieve project goals while implementing innovative solutions for GMP‑compliant manufacturing systems.

Responsibilities

• Lead the planning, design, and execution of engineering projects for single‑use biologics process equipment.
• Manage sub‑project budgets, schedules, resources, and risks to ensure timely and cost‑effective project delivery.
• Serve as the primary interface with equipment suppliers for technical specifications, design reviews, and performance validation.
• Oversee Factory Acceptance Tests, Site Acceptance Tests, and equipment qualification activities, ensuring systems meet GMP compliance.
• Develop and manage relationships with external vendors and contractors to ensure quality execution and timely delivery of project scope.
• Provide mentoring and technical guidance to less experienced engineers to foster professional growth and team excellence.
• Drive alignment with key stakeholders, ensuring consistent communication and decision‑making throughout project phases.

Qualifications

• Bachelor’s Degree in Chemical Engineering, Mechanical Engineering, or related discipline with 8+ years of experience preferably in pharmaceutical biologics molecule drug substance equipment, and 6+ years of experience with a Master’s Degree.
• Experience managing international capital projects related to biologics molecule drug substance equipment, with typical project budgets ranging from 15 to 50mCHF.
• Operational experience with biologics systems (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%) 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.
• Preferred: MS in Engineering (Chemical or Mechanical) and/or an MBA.

Benefits and Compensation

The expected salary range for this position based on the primary location of California is $109,900 – $204,100 per year. 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 in this link. Relocation benefits are not available for this posting. This is an on‑site position; no remote options are available at this time.

EEO Statement

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.