Principal​/Senior Principal Process Engineer, Aseptic Operations​/Filling

Overview

Genentech's Hillsboro Technical Operations (HTO) in Hillsboro, Oregon focuses on drug product manufacturing across Component Prep & Compounding, Liquid/Lyophilized Filling, Automated/Manual Inspection, Packaging/Finished Products, and Distribution. The site is expanding and seeks a Principal or Senior Principal Process Engineer to lead product technology transfers, optimize processes, and deploy new technologies while maintaining the highest quality standards.

• Lead and support product technology transfers to the HTO site.
• Collaborate with cross‑functional teams, including Manufacturing, Quality Assurance, and Engineering Science & Technology, to ensure regulatory compliance.
• Provide guidance to Process Engineering – Filling group engineers on operations.
• Plan and execute technology transfers and process validation activities; manage projects, develop protocols, conduct execution, and produce reports.
• Support equipment qualification and commissioning for new manufacturing equipment and processes.
• Prepare and present rationale for tech transfer activities during periodic audits and regulatory inspections.
• Author, review, and approve relevant sections of regulatory submissions.
• Represent the site on cross‑functional and multi‑site teams for tech transfers and new technologies.
• Lead and facilitate Gap Assessments, Risk Assessments, and other deliverables for tech transfers and NME launches.
• Mentor and train junior level engineers.
• Maintain expertise in aseptic processing and stay abreast of technical and industry advancements.

• Bachelor’s or Master’s degree in Engineering, Pharmaceutical Sciences, or a related field.
• Minimum 8 years of relevant experience for Principal Engineer, 12 years for Senior Principal Engineer.
• Experience in the pharma/biotech industry.
• Strong knowledge of pharmaceutical/biologics processing principles, cGMP regulations, and regulatory requirements (FDA, EMA).
• In‑depth knowledge of formulation, component preparation, and/or filling process development and characterization.
• Proficiency in data analysis and statistical tools for process monitoring and optimization.
• Excellent problem‑solving, troubleshooting, and root cause analysis skills.
• Professional communication and collaboration skills with a cross‑functional team orientation.
• Detail‑oriented with a commitment to compliance and high‑quality results.

Salary ranges for Hillsboro, OR: $114,380 – $212,420 for Principal level and $138,000 – $256,750 for Senior Principal level. Actual pay is based on experience, level, qualifications, geographic location, and other factors permitted by law. A discretionary annual bonus may be available. Relocation benefits are also provided.

Genentech is an equal opportunity employer. We employ, promote, and otherwise treat all employees and applicants on the basis of merit, qualifications, and competence. Our policy prohibits unlawful discrimination, including but not limited to discrimination on the basis of protected veteran status, disability 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 complete the Accommodations for Applicants form.