Process Engineer Ii/Senior Engineer, Packaging/Visual Inspection

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.

The Opportunity:

We are seeking a skilled process engineer to join our dynamic team with a focus on providing day-to-day operations support for our Aseptic Filling Operations with a focus on the Visual Inspection and Packaging Processes. As a Process Engineer, you will play a crucial role in ensuring the smooth and efficient operation of our visual inspection and packaging 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.

• You will provide technical expertise and support for Inspection and Packaging operations, including process troubleshooting, optimization, and improvement initiatives.

• You will provide technical support and expertise for drug product manual visual inspection, semi-automated Inspection, automated inspection operations, and packaging operations.

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

• You will perform product complaint assessments and or investigations, and other related post-market surveillance activities.

• You will 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.

• You will utilize Lean Production System elements and methods to continuously improve Engineering tactical business processes and procedures.

• 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 support regulatory inspections and audits by providing technical expertise and documentation.

• 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 you are:

• You have a Bachelor's degree in Engineering, Pharmaceutical Sciences, or a related technical field.

• You have significant relevant bio/pharmaceutical experience preferably in aseptic manufacturing operations. (Engineer II = 4-7 years, Senior Engineer = 8-11 years)

• You have strong knowledge of cGMP regulations and quality systems, with experience working in a regulated environment.

• You have a proven ability to troubleshoot equipment issues and implement process improvements.

• You have significant experience with visual inspection systems, including automated, semi-automated, and manual, and packaging processes in a cGMP environment

• You are proficient in data analysis and statistical tools for process monitoring and optimization.

• You are detail-oriented with strong analytical and problem-solving skills, with the ability to identify root causes and implement effective corrective actions.

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

Preferred

• Experience with qualification and validation protocols is preferred.

• Familiarity with Lean Six Sigma principles and continuous improvement methodologies

The expected salary range for this position (Engineer II - Senior Engineer) based on the primary location of Hillsboro, OR is $65,000 - $175,000. 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 Benefits

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