Job Details

The Position

Genentech's Hillsboro Technical Operations (HTO), located in Hillsboro, Oregon, specializes in drug product manufacturing, including component preparation, compounding, liquid and lyophilized filling, automated/manual inspection, packaging, finished products, and distribution. This site is experiencing growth and offers opportunities to optimize existing processes and implement new capabilities and technologies. It plays a vital role in a global network of industry-leading pharmaceutical manufacturing facilities, ensuring reliable supply of medicines to patients worldwide.

What you will do:

As a Principal / Senior Principal Process Engineer, you will lead or support product tech transfers at the HTO site, ensuring smooth and efficient transfer processes while maintaining high quality standards. You will collaborate with Manufacturing, Quality Assurance, and Engineering Science & Technology teams to ensure regulatory compliance and support operations by guiding other engineers within the Process Engineering - Filling group.

• You will lead and participate in technology transfers and process validation activities, including project management, protocol development, execution, and report writing.
• You will support equipment qualification and commissioning activities for new manufacturing equipment and processes.
• You will prepare and present justifications for tech transfer activities during audits and regulatory inspections.
• You will author, review, and approve sections of regulatory submissions.
• You will represent the site on cross-functional and multi-site teams to support tech transfers and new technologies.
• You will lead and facilitate Gap Assessments, Risk Assessments, and other deliverables for tech transfers and NME launches.
• You will mentor and train junior engineers.
• You will foster an environment of continuous learning, staying updated on technical and industry advancements related to aseptic processing.

Who are you:

• You hold a BS/MS in Engineering, Pharmaceutical Sciences, or a related field, with a minimum of 8 years of relevant experience for Principal Engineer or 12 years for Senior Principal Engineer.
• You have experience in the pharma/biotech industry.
• You possess strong knowledge of pharmaceutical/biologics processing principles, cGMP regulations, and regulatory requirements (e.g., FDA, EMA).
• You have in-depth knowledge of formulation, component preparation, and/or filling process development and characterization.
• You are proficient in data analysis and statistical tools for process monitoring and optimization.
• You have excellent problem-solving and troubleshooting skills, with the ability to identify root causes and implement corrective actions.
• You possess professional communication and collaboration skills to work effectively in cross-functional teams.
• You are detail-oriented, committed to compliance, and focused on delivering high-quality results.

The expected salary range for this position in Hillsboro, OR is $114,380 - $212,420 for Principal Level and $138,000 - $256,750 for Senior Principal level. Compensation will be based on experience, qualifications, and other factors. A discretionary annual bonus may be available, and the role qualifies for relocation benefits.

Link to Roche/Genentech Benefits

Genentech is an equal opportunity employer. We prohibit discrimination based on protected statuses and comply with all applicable laws.

If you need accommodations during the application process due to a disability, please complete our Accommodations for Applicants form.