Senior​/Principal Clean Utilities Specialist - CVRM (Holly Springs

Are you ready to build the future of biomanufacturing from the ground up? At Roche and Genentech, we are investing $2B to create a state-of-the-art, greenfield facility in Holly Springs, North Carolina. This pioneering site is destined to change the landscape of patient care, serving as a critical hub for our Cardiovascular, Renal, and Metabolic (CVRM) mission—directly targeting global health challenges like obesity and diabetes.

As we march toward our 2028 operational launch, we are not just building walls and installing piping; we are assembling a team of elite pioneers.

We are seeking a highly skilled and motivated maintenance specialist with direct experience in the operation and maintenance of clean utility and plant utility systems. This individual will be accountable for leading troubleshooting efforts, supporting system start-up, providing coaching and training to other personnel, and serving as owner or functional representatives on projects. In addition, they will be accountable to support maintenance of process equipment and infrastructure throughout the Holly Springs site.

As a Principal Clean Utilities System Specialist / Senior Clean Utilities System Specialist within Facilities & Engineering, you will own the integrity, reliability, and compliance of the critical lifelines of our manufacturing process. Without your expertise in high-purity systems, our state-of-the-art facility cannot deliver life-saving therapeutics. You are someone who thrives in the ambiguity of a startup environment, values safety above all else, and executes with the uncompromising rigor of a world-class cGMP organization.

During the plant start-up project, you will serve as a user team representative and be responsible for establishing the site’s maintenance program for clean utility systems. This will include development of procedures and training programs, spare part strategy, master data creation, and maintenance plan creation. You will also support FATs and SATs for clean utility equipment and process equipment as needed.

While this role is focused on Clean Utilities, you are expected to be able to flex to support other asset management functions of the Holly Springs site. You will provide technical support through all phases of the project, including design review, installation, commissioning, qualification, and system turnover. You will partner and collaborate with other organizations such as Engineering, MSAT, Quality, QC, Supply Chain, and Production to accomplish this.

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

You will provide in the field execution of maintenance activities on GMP assets. This will include both planned preventative maintenance and repairs / troubleshooting. Supporting troubleshooting of PLC/automation is expected. This will be done while adhering to applicable SOPs, complying with cGMP, and adhering to Federal, State, Local, and Genentech safety standards. You will operate, maintain, and repair site utility infrastructure equipment within a cGMP facility, including utilities, electrical, and HVAC systems;

not limited to water-for-injection, chilled water, clean steam, heating hot water, cold rooms, cooling towers, fire protection, and control systems supporting 24/7 manufacturing, lab, and warehouse operations. You will perform accurate and timely detailed documentation following Good Documentation Practices in electronic (e.g. SAP) and paper based systems. You will create and facilitate continuing education for the maintenance staff to increase technical skills through formal and informal training, coaching and mentorship.

You will provide assistance with identification of spare parts and BOM improvements to improve service delivery and reduce equipment downtime. You will need to Read and Understand P&lDs, work from Standard Operating Procedures (SOPs)…