Principal Project Engineer for Single-Use Equipment

Reposted 23 Days Ago
Be an Early Applicant
Oceanside, CA, USA
In-Office
110K-204K Annually
Senior level
Healthtech • Biotech
The Role
Manage engineering projects focused on single-use systems in biologics manufacturing, ensuring compliance and collaboration across global teams and stakeholders.
Summary Generated by Built In

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 member of this team, you will play a pivotal role in managing complex projects, collaborating with multidisciplinary teams, and ensuring compliance with industry and regulatory standards. This position offers the opportunity to work with global stakeholders, mentor engineers, and contribute to the advancement of innovative technologies that support our mission of delivering high-quality, life-saving medicines to patients worldwide.

The Opportunity

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. Additionally, you will:

  • 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.

Who You Are

  • Bachelor's Degree in Chemical Engineering, Mechanical Engineering, or related discipline with 8+ years of experience preferably in pharmaceutical biologics molecule drug substance equipment, 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 50m CHF.

  • 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%) 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.

Preferred: 

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

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

​Relocation benefits are not available for this posting.

The expected salary range for this position based on the primary location of California is $109,900 - $204,100 Annual. 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.

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.

Skills Required

  • Bachelor's Degree in Chemical Engineering or Mechanical Engineering
  • 8+ years of experience in pharmaceutical biologics equipment
  • Experience managing international capital projects related to biologics
  • Operational experience with biologics systems
  • Experience with regulatory compliance and GMP requirements

Genentech Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Genentech and has not been reviewed or approved by Genentech.

  • Healthcare Strength Health coverage is described as comprehensive across medical, dental, vision, mental health, and prescriptions, supported by HSAs/FSAs and broad wellness resources. On‑site fitness and health centers, mental‑health clinicians, and specialized programs like fully covered preventive cancer screenings and menopause support deepen the offering.
  • Retirement Support Retirement benefits feature a 401(k) with up to a 4% company match plus an additional annual 6% company contribution to eligible pay. Additional financial protections such as life and accident insurance complement salary, bonuses, and stock options.
  • Leave & Time Off Breadth Time away includes about 20 paid vacation days, paid holidays, personal days, and a year‑end shutdown. A paid six‑week sabbatical every six years notably expands long‑term time‑off flexibility.

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The Company
HQ: South San Francisco, CA
20,069 Employees
Year Founded: 1976

What We Do

Considered the founder of the industry, Genentech, now a member of the Roche Group, has been delivering on the promise of biotechnology for more than 40 years. Genentech is a biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. We're passionate about finding solutions for people facing the world's most difficult-to-treat conditions. That is why we use cutting-edge science to create and deliver innovative medicines around the globe. To us, science is personal. Making a difference in the lives of millions starts when you make a change in yours.

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