Principal/Senior Principal Process Engineer, Visual Inspection

About the position

The 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. 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 Process of semi-finished products. As a Process Engineer, you will play a crucial role in ensuring the smooth and efficient operation of our visual inspection 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.

Responsibilities

• Provide technical expertise and support for Inspection operations, including process troubleshooting, optimization, and improvement initiatives.
• Provide technical support and expertise for drug product 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.
• Train and mentor team members to enhance their skills and promote professional growth.

Requirements

• Bachelor's degree in Engineering, Pharmaceutical Sciences, or a related technical field.
• Minimum of 8+ years of relevant bio/pharmaceutical experience preferably in cGMP manufacturing or manufacturing support.
• Strong knowledge of cGMP regulations and quality systems, with experience working in a regulated environment.
• Proven ability to troubleshoot equipment issues, implement process improvements, and qualify and validate process equipment.
• Recognized as an expert with visual inspection systems, including automated, semi-automated, and manual processes in a cGMP environment.
• Proficient in data analysis and statistical tools for process monitoring and optimization.
• Detail-oriented with strong analytical and problem-solving skills, with the ability to identify root causes and implement effective corrective actions.
• Strong written and verbal communication.
• Ability to work independently and challenge the status quo, handle multiple projects, prioritize and delegate effectively, adapt to changes quickly, and work collaboratively on cross-functional teams.
• Demonstrated project management skills.

Nice-to-haves

• Experience with qualification and validation protocols is preferred.
• Familiarity with Lean Six Sigma principles and continuous improvement methodologies is a plus.

Benefits

• Relocation benefits
• Discretionary annual bonus based on individual and Company performance