Senior Automation Manager - Holly Springs

Welcome to Holly Springs, North Carolina— home to Roche/Genentech's largest-ever investment: a $2B greenfield start-up where next-generation technology, high-performing teams and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing.

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 meets today’s demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines and is scalable to grow with the portfolio, which focuses on next-generation metabolic medicines specifically targeting the global obesity epidemic and Type 2 diabetes.

This is a fast-paced, entrepreneurial environment with a high-level of accountability, with planned launch in 2028.

ITOT supports Pharma Technical Manufacturing (PTM), PTM is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply. From the raw material to the final medicine, we contribute to deliver Roche’s ground-breaking therapies to more than 120 million patients around the world. We make our medicines at 9 sites around the world and coordinate all aspects of production of Roche medicines in all disease areas and dosage forms.

To ensure readiness for a step-change in the standard of care that Roche delivers in the area of Cardiovascular, Renal and Metabolism (CVRM), PTM will construct a new manufacturing site in the U.S. in Holly Spring, North Carolina. ITOT will own and operate Manufacturing Technology stack at the site working with Global IT. The new site will focus on large volume low cost Drug Product manufacturing (Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products).

Senior Automation Manager is being hired to participate in Greenfield Project execution and then support the facility after going live.

Once hired, the official title will be Control Systems Lead .

Initially, you will perform a mix of remote and onsite work (first at the General Planner’s office, later at construction site/plant). You will transition to local full time on-site work once the site buildings are built and equipment delivered. Travel of up to 30% of the time is expected during the project phase.

Senior Automation Manager will be Responsible for providing automation ad instrumentation and controls engineering capabilities and experience to the ITOT / Automation Engineering Group including generating qualification protocols and maintaining the validated state of systems and processes. Initially, participates in Basic Design, Detailed Design and Facility Startup. Eventually focuses on providing long-term support for newly built facilities with respect to the automation and instrumentation and control systems for process, utility and building systems.

Lead automation impacting projects with large and/or complex scope. Drive strategic initiatives to improve business processes. Be both a People Leader/ Coach and at times hands on SME.

• Manage and lead the site automation engineering team, overseeing professional development and daily operations.
• Drive the automation strategy for the facility, ensuring alignment with global standards and local manufacturing needs.
• Oversee the design, commissioning, and validation of process control systems for the Greenfield project.
• Establish and maintain robust life cycle management for all site control and manufacturing systems.
• Partner with IT and Quality stakeholders to ensure data integrity and compliance across…