Principal Project Engineer for Single-Use Equipment

Genentech; Oceanside (CA); On-site; USD 100,000 - 130,000; Full time

Job summary

A leading biotechnology company is seeking a Senior Technical Sub-Project Manager for Single-use Systems in Oceanside. This role involves overseeing engineering projects focused on biologics process equipment, ensuring compliance with regulatory standards and Roche guidelines. The successful candidate will manage budgets, schedules, and collaborate with global teams while providing mentorship to junior engineers. Candidates must have a Bachelor's in Engineering with extensive experience in biologics systems and project management, including significant international travel.

Qualifications

• 8+ years of experience in pharmaceutical biologics equipment.
• Experience managing capital projects with budgets of 15 to 50m CHF.
• Operational experience with biologics systems and regulatory compliance.

Responsibilities

• Lead engineering projects for single-use biologics process equipment.
• Manage sub-project budgets, schedules, and resources.
• Oversee Factory and Site Acceptance Tests for GMP compliance.

Skills

Project management

Technical specifications

Regulatory compliance

Collaboration with stakeholders

Education

Bachelor's Degree in Chemical or Mechanical Engineering

Master’s Degree (preferred)

Tools

Bioreactors

Chromatography skids

Filtration systems

Centrifuges

Laminar flow hoods

Job description

The Position

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 Senior Technical Sub-Project Manager for Single-use Systems, 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‑size 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: