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The Position Genentech's Hillsboro Technical Operations (HTO), located in Hillsboro, Oregon, is involved in drug product manufacturing, including component preparation, compounding, liquid/lyophilized filling, inspection, packaging, finished products, and distribution. The site is experiencing growth and offers opportunities to optimize existing processes and implement new capabilities and technologies. It is a key part of a global network of pharmaceutical manufacturing facilities, playing a critical role in supplying medicines to patients worldwide. What you will do: You will provide leadership and support for product tech transfers at the HTO site. As a Principal / Senior Principal Process Engineer, you will ensure smooth product transfers while maintaining high quality standards. You will collaborate with Manufacturing, Quality Assurance, and Engineering Science & Technology teams, ensuring regulatory compliance. You will also support other engineers in the Process Engineering - Filling group, offering guidance and expertise. You will lead and participate in technology transfers and process validation activities, including project management, protocol development, execution, and reporting. You will support equipment qualification and commissioning for new manufacturing equipment and processes. You will prepare and present justifications for tech transfer activities during audits and inspections. You will author, review, and approve sections of regulatory submissions. You will serve as a site representative on cross-functional and multi-site teams to support tech transfers and new technologies. You will lead Gap Assessments, Risk Assessments, and other deliverables for tech transfers and NME launches. You will mentor and train junior engineers. You will promote continuous learning and stay 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 at least 8 years (Principal) or 12 years (Senior Principal) of relevant experience. 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. You have professional communication and collaboration skills. You are detail-oriented and committed to compliance and quality. The salary range for this position in Hillsboro, OR is $114,380 - $212,420 for Principal and $138,000 - $256,750 for Senior Principal, depending on experience and qualifications. The role may include a discretionary bonus and relocation benefits. For more details, see the Roche/Genentech

Benefits

link. Genentech is an equal opportunity employer, committed to diversity and inclusion. Accommodations are available for applicants with disabilities.

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