Process Engineering Lead, Automated Visual Inspection; Holly Springs

The Position

Welcome to Holly Springs, North Carolina— home to Genentech's largest-ever investment with an ambitious goal to be a fully connected Plant of the Future. This is where next-generation technology, capability, digital connectivity and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing. This will include Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products.

The facility's core is defined by innovation - leveraging advanced automation, robotics, digital tools, real-time data analytics, and simple, streamlined processes to produce the highest quality medicines. This plant will not only meet today’s demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines but is a strategic commitment to be scalable with this portfolio, which serves one of the largest patient populations in the world.

This is a fast-paced, highly entrepreneurial environment with a high-level of accountability from the site team to launch operations in 2028.

Are you a problem-solver and change agent who thrives in a High-Performing Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to not only launch a state-of-the-art facility from the ground-up but to shape the culture of our organization for the next generation. Join us in Holly Springs, where you won''t just build a plant—you will build the future of medicine.

We re seeking a highly experienced and strategic Process Engineering Leader to oversee the design, qualification and operational startup of the Automated Visual Inspection (AVI) program in our state-of-the-art manufacturing site.

Your initial focus will be to provide scientific, technical, and operational leadership to establish the new AVI operation within the Drug Product Fill and Finish facility. This involves partnering and collaborating with the Engineering Delivery team, equipment suppliers, the newly formed local site team and Roche/Genentech network Visual Inspection teams to establish a green-field AVI program from the ground-up.

Key Start-up Responsibilities:

• Collaborate closely with the Roche VI network, industry experts, and technology suppliers to implement the latest, fit-for-purpose Vision Technology.

• Contribute expertise in project management, technical design, testing, qualification, recipe development and validation to ensure successful installation, qualification and validation of the program.

• Ensure the overall AVI program, to include defect program, operator qualification program, general operating procedures, maintenance and calibration programs meet the latest and highest global health authority, regulatory standards for successful registration and filing.

• Ensure optimum equipment selection through qualification in place to deliver a Vertical Ramp Up with high quality defect detection and minimal waste.

• Be an integral part of selecting, training, qualifying, and mentoring Operators and Maintenance Technicians,

• Build long term training plans, provide knowledge and training on complex process and equipment technologies to all required partners. Provide training materials and training for people joining the organization. Act as a coach for colleagues with less experience and help them develop skills/expertise.

• Together with the suppliers and contractors, build all required processes, documents, tests to transition the design plans into a functioning, approved manufacturing process.

Post Go-Live Responsibilities:

Following the facility s go-live, you will transition to supporting the ongoing AVI Business Unit, which delivers a high-speed inspection program of the highest quality. In this sustained operations phase, you will:

• Become the Engineering process expert for all site Machine Vision systems.

• Drive Continuous Improvement and optimization to improve quality, yield and OEE of the assets.

• Monitor and analyze machine performance, trend data and performance parameters to predict and proactively improve the program.

• Keep up to date with the latest in industry changes and…