Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio & pipeline products.  The Operations organization at HTO is divided into 2 value streams, which combine to produce millions of units of life-saving medicine every year to patients around the world.

What you will do:

In this exciting position, you will focus on providing day-to-day operations support for our Aseptic Filling Operations. As a Senior / Principal Process Engineer, you will play a crucial role in ensuring the smooth and efficient operation of our aseptic filling processes, while maintaining the highest quality standards.  You will work closely with cross-functional teams, including Manufacturing, Quality Assurance, and Engineering Science & Technology, to drive process improvements, troubleshoot issues, and ensure compliance with regulatory requirements. You will support other front-line engineers, providing guidance and expertise in support of manufacturing.

You will provide technical expertise and support for aseptic filling operations (formulation, vial and prefilled syringe filling, isolators, lyophilization, and capping) and front-line engineers, including process troubleshooting, optimization, and improvement initiatives.

You will participate in technology transfers and process validation activities, including protocol development, execution, and report writing.

You will support equipment qualification and commissioning activities for new manufacturing equipment and processes.

You will perform data gathering, root cause analysis, performance trending, and develop appropriate process control changes for complex issues, deviations, and product complaints.

You will collaborate with cross-functional teams to develop and implement process improvements related to product quality, yield, and efficiency; ensuring optimized and efficient manufacturing operations, as well as compliance with regulatory requirements and industry best practices.

You will foster an environment that encourages continuous learning, maintaining expertise to stay abreast of technical and industry advancements and best practices related to aseptic processing.  

You will consistently collaborate with manufacturing personnel and front-line engineers to develop best practices for supporting the manufacturing operation, ensuring front-line engineers are providing the expected level of service.

Who are you:

You hold a Bachelor's degree in Engineering, Pharmaceutical Sciences, or a related field, and have the minimum years of relevant experience (Senior Engineer = 5-7 years, Principal Engineer = minimum 8).

You have a strong knowledge of pharmaceutical/biologics processing principles, cGMP regulations, and regulatory requirements (e.g., FDA, EMA).

You have experience with aseptic filling equipment and processes, such as isolators, filling machines, lyophilizers, and sterilization.

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 effective corrective actions.

You have strong communication and collaboration skills, with the ability to work effectively in a cross-functional team environment.

You are detail-oriented, with a commitment to ensuring compliance and delivering high-quality results.

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The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $80,500 - $149,500 for the Senior level and $95,200 - $176,000 for the Principal Level . Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Please note this role is eligible for relocation benefits.

Link to Roche/Genentech Benefits

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.