Principal Process Engineer

Genentech • Hillsboro, OR

2d • Onsite

About The Position

Genentech’s Hillsboro Oregon campus—Hillsboro Innovative Therapies (HIT)—serves as a critical hub for emerging cell & gene therapy manufacturing. Housed within a modern 75-acre facility just outside Portland, HIT is at the forefront of advancing cell and gene therapy medicines through accelerated clinical and commercial manufacturing capabilities, aligning with Genentech’s mission to bring transformative therapies to patients. This role is a key part of our innovative Manufacturing Sciences and Technology (MSAT) team, dedicated to advancing transformative therapies for patients. The MSAT team drives the development, optimization, and validation of cutting-edge manufacturing processes, working at the intersection of science and engineering. As part of this collaborative and dynamic group, you will partner with experts across Engineering, Process Development, Manufacturing, and Quality to support technology transfer, process optimization, and pioneering solutions in medicine production. The Opportunity: As a Principal Process Engineer , you lead and support various aspects of the design, and startup of novel therapies manufacturing processes and will be responsible for various aspects of the process validation and technology transfer. In addition, you will be involved with hands-on experimentation in the MSAT process optimization laboratory and will be accountable for providing technical support to the manufacturing operation, including process monitoring and optimization, as well as authoring technical assessments. Additionally, you will:

Requirements

• You possess a Bachelor’s degree in a relevant scientific or engineering discipline (Chemical Engineering, Life Sciences or related) with at least 8 years of relevant industry experience in manufacturing sciences, biotechnology, or pharmaceutical development.
• You possess a proven ability to provide technical leadership without formal authority, navigating a complex matrixed environment to align goals across Engineering, Manufacturing, Quality, and Development.
• You have at least 8 years of experience leading the design, development, and implementation of innovative processes to support the manufacturing of transformative therapies including cell culture experiments to support advanced modalities.
• You have significant expertise designing and conducting hands-on experimentation in the MSAT process optimization laboratory to refine and optimize processes or in support of deviation investigations.
• You have deep expertise in cGMP environments, with a track record of successfully leading Process Performance Qualification (PPQ) and authoring CMC sections for regulatory filings.
• You thrive in "startup" style environments within a larger organization, demonstrating the agility to manage multiple high-priority projects while maintaining a rigorous focus on patient safety and product quality.
• You possess excellent written and verbal communication skills, and the ability to present data and write reports.

Responsibilities

• Lead End-to-End Technology Transfer: Drive the seamless transition of complex cell and gene therapy (CGT) processes from clinical development to commercial-scale manufacturing, ensuring phase-appropriate validation and regulatory compliance.
• Architect Process Design & Scale-up: Spearhead the design, equipment selection, and startup of novel manufacturing suites, utilizing engineering principles to solve unique scale-up challenges inherent in individualized medicine.
• Drive Laboratory Excellence: Execute hands-on experimentation within the MSAT process optimization lab to troubleshoot manufacturing deviations, define design spaces, and identify opportunities for yield and purity enhancement.
• Establish Process Control Strategies: Author and oversee comprehensive technical assessments, process monitoring programs, and validation protocols to ensure robust, reproducible, and "right-first-time" manufacturing operations.
• Champion Continuous Improvement: Identify and implement innovative process-centric solutions and digital tools that reduce cycle times, minimize waste, and enhance the safety profile of emerging therapies.
• Serve as a Technical Authority: Provide 24/7 high-level technical support for floor operations, acting as the primary subject matter expert (SME) during health authority inspections and complex investigations.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• This position also qualifies for the benefits detailed at this link .
• Relocation benefits are approved for this position.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Number of Employees: 5,001-10,000 employees