Process Engineer/Senior Process Engineer, Filling
About The Position
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. 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.
Requirements
- Bachelor's degree in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, or a related field
- 0-2 years of relevant experience (Engineer) or 3-7 years of experience (Senior)
- Strong knowledge of pharmaceutical/biologics processing principles, cGMP regulations, and regulatory requirements (e.g., FDA, EMA)
- Proficient in data analysis and statistical tools for process monitoring and optimization.
- Excellent problem-solving and troubleshooting skills, with the ability to identify root causes and implement effective corrective actions.
- Strong communication and collaboration skills, with the ability to work effectively in a cross-functional team environment.
Nice To Haves
- Experience with aseptic filling equipment and processes, such as isolators, filling machines, lyophilizers, and sterilization is preferred
Responsibilities
- Provide technical expertise and support for aseptic filling operations, including process troubleshooting, optimization, and improvement initiatives.
- Provide technical support and expertise for aseptic filling operations, including vial and prefilled syringes filling, isolators, lyophilization, and capping.
- Participate in process validation activities, including protocol development, execution, and report writing.
- Support equipment qualification and commissioning activities for new manufacturing equipment or processes.
- Participate in technology transfer activities from development to commercial manufacturing, ensuring successful scale-up and process validation.
- Perform data gathering, root cause analysis, and performance trending to develop appropriate process control changes for complex issues.
- Prioritize and implement process change requirements based on the critical project needs.
- Lead change management system for process changes and or new processes.
- 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.
- 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.
Benefits
- A discretionary annual bonus may be available based on individual and Company performance.
- Benefits detailed at the link provided below.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
