Roche · 1 month ago
Principal Process Engineer
Hillsboro
Full-time
Onsite
Senior Level, Lead/Staff
$95K/yr - $177K/yr
8+ years expGenentech’s Hillsboro Oregon campus is a critical hub for emerging cell & gene therapy manufacturing. The Principal Process Engineer will lead and support the design and startup of novel therapies manufacturing processes, ensuring seamless technology transfer and robust process validation.
BiotechnologyHealth CareHealth DiagnosticsOncologyPharmaceuticalPrecision Medicine
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
Qualification
Required
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
Benefits
A discretionary annual bonus may be available based on individual and Company performance.
Relocation benefits are approved for this position.
Company
Roche
Roche is a pharmaceutical and diagnostics company that offers medicines and diagnostic tests for various medical conditions and diseases.
10001+ employees
H1B Sponsorship
Roche has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (9)
2023 (6)
2022 (2)
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$7.79BKey Investors
SoftBankSCALE AINovartis
2021-08-04Post Ipo Equity· $5B
2020-12-07IPO
2020-05-06Post Ipo Equity· $0.5M
Leadership Team
Alan Hippe
Member of the Executive Board - Group CFO
Christine Bakan
Global Head and VP of Software and Bioinformatics, Next Generation Sequencing
Recent News
2026-01-22
2026-01-22
Company data provided by crunchbase