The Opportunity
In this exciting position, you will focus on providing day-to-day operations support for our Aseptic Filling Operations. As a 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 and Technology, to drive process improvements, troubleshoot issues, and ensure compliance with regulatory requirements.
You will provide technical expertise and support for aseptic filling operations, including process troubleshooting, optimization, and improvement initiatives.
You will provide technical support and expertise for aseptic filling operations, including vial and prefilled syringes filling, isolators, lyophilization, and capping.
You will participate in process validation activities, including protocol development, execution, and report writing.
You will support equipment qualification and commissioning activities for new manufacturing equipment or processes.
You will participate in technology transfer activities from development to commercial manufacturing, ensuring successful scale-up and process validation.
You will perform data gathering, root cause analysis, and performance trending to develop appropriate process control changes for complex issues.
You will prioritize and implement process change requirements based on the critical project needs.
You will lead change management system for process changes and or new processes.
You will collaborate with cross-functional teams, including manufacturing, quality, and validation, to develop and implement process improvements, 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. Maintain expertise as necessary to stay abreast of technical and industry advancements, and best practices related to aseptic processing.
Who are you:
You hold a Bachelor's degree in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, or a related field and have 0-2 years of relevant experience (Engineer) or 3-7 years of experience (Senior)
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 is preferred
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.
The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $78,900 - $146,500. 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 not eligible for relocation benefits.
Link to Roche/Genentech
