THE POSITION

The Hillsboro Technical Operations (HTO) is a drug product and finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio & pipeline products. The Manufacturing organization at HTO is divided into Aseptic Operations and Packaging, which combine to produce millions of units of life-saving medicine every year to patients around the world.

SUMMARY:

The Senior Manufacturing Engineer in Aseptic Operations will serve as the technical leader responsible for optimizing, maintaining, and troubleshooting equipment and processes within our sterile manufacturing operations. This individual will drive continuous improvement, support new product introductions, and ensure the robust and compliant production of Roche’s commercial portfolio and pipeline products. A deep understanding of aseptic techniques, cGMP, regulatory requirements, and advanced automation in a sterile environment is paramount for this role.

KEY RESPONSIBILITIES:

• Collaborate with cross-functional teams, including, Quality, Automation, Process Engineering and Validation to troubleshoot and solve complex problems.
• Identify and implement process improvements to enhance line efficiency, reduce scrap/rejects, optimize cycle times, and increase yield within the aseptic core and downstream areas.
• Troubleshoot and resolve technical issues in a timely manner.
• Provide expert engineering support for complex manufacturing deviations, non-conformances, and quality events specific to aseptic processing.
• Design and develop mechanical systems, components, and products using advanced engineering principles and techniques.
• Proven ability to apply structured problem-solving techniques (e.g., 8D, Fishbone, 5 Whys, FMEA) to complex, high-impact manufacturing and sterility-related issues.
• You will manage documentation including deviations, work orders, work instructions and SOP’s.