Process Engineer II/Senior Engineer, Visual Inspection

4 weeks ago

Hillsboro, United States Genentech Full time

The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. 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. The Opportunity: This role is a valuable part of the Process Engineering team, and will focus on providing day-to-day operations support for our Aseptic Filling Operations with a focus on Visual Inspection Process. 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. As a member of this team, 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. What you’ll do Provide technical expertise and support for Inspection operations, including process troubleshooting, optimization, and improvement initiatives.

Provide technical support and expertise for aseptic filling operations, including vial and prefilled syringes manual visual inspection, semi-automated Inspection, and automated inspection operations

Perform data gathering, root cause analysis, and performance trending to develop appropriate process control changes for complex issues.

Perform product complaint assessments and or investigations, and other related post-market surveillance activities.

Conduct process investigations and root cause analyses to identify and address deviations, non-conformances, and other process-related issues, implementing corrective and preventive actions as necessary.

Utilize Lean Production System elements and methods to continuously improve Engineering tactical business processes and procedures.

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.

Support regulatory inspections and audits by providing technical expertise and documentation.

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 you are: You hold a Bachelor's degree in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, or a related field.

You have significant relevant bio/pharmaceutical experience preferably in aseptic manufacturing operations.

(Engineer II = 4-7 years, Senior Engineer = 8-11 years)

Strong knowledge of aseptic processing principles, cGMP regulations, and regulatory requirements (e.g., FDA, EMA).

You have extensive experience with aseptic filling equipment and processes, including visual inspection systems in a cGMP environment

You are 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.

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.

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