Principal Plant Engineer - HVAC, CVRM

Genentech

Holly Springs, NC

Pay: $95,200-$176,800/yr

Shift: Full time

The Position

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.

Are you a problem-solver and change-agent who thrives in a Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to launch a state-of-the-art facility from the ground-up and 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.

**The Opportunity**

We're seeking a highly skilled and experienced Principal Plant Engineer who will be the site’s highest-level technical subject matter expert (SM) for the site’s HVAC/R program, including end-to-end asset management for all HVAC, refrigeration, and cold/warm room systems and plant utilities.

**What You'll Do**

*Pre-Startup:*

During the plant start-up project you will be on the User Team and be accountable for establishing the site’s foundational asset management program for HVAC-R and plant utility systems. In partnership with Project Engineering and the start-up project (user) team you will partner and collaborate with our partner site organizations (Engineering and MSAT, Quality, Supply Chain, Technical Development, Regulatory, CMO, Strategy) to provide expertise in project management and technical design, testing, qualification, validation, as well as all other activities related to design and start-up a new Drug Product Fill and Finish facility with a focused lens on HVAC/R systems such as air handling units, chillers, cooling towers hot water units and cold rooms.

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.

*Post-Startup:*

You will provide strategic and tactical leadership to ensure that the facility's HVAC systems operate with maximum reliability and in strict compliance with cGMP standards.

• You will drive optimal greenfield facility and operations design towards high manufacturing efficiency and quality in line with product and regulatory requirements. This includes inputs to the creation of master data and maintenance programs in SAP S4/HANA, our Computerized Maintenance Management Software.
• Oversee HVAC/R and Cleanroom Performance Testing contract services, as needed, to ensure maintenance needs are met and evaluate vendors or service contractor performance. This includes in the field troubleshooting, root cause analysis, and deviation, change control, and CAPA ownership. This will require strong collaboration with Automation, Validation, Calibration, Quality, and Manufacturing.
• You will own utility, HVAC/R, electrical, and control systems serving the manufacturing site and ensure a state of continuous compliance and audit readiness through the application of good engineering practices and troubleshooting methodologies.
• You will develop and optimize a reliability program for HVAC/R equipment and site infrastructure and proactively manage instrumentation/equipment obsolescence and improvement projects.
• You understand the bigger picture of the project and the CVRM disease area and how PT contributes to it. Works closely with the overall project team, the wider organisation and interdepartmental staff to meet department and company goals. Effectively partners with and influences stakeholders across the organization without formal authority, and drives technical decisions balancing product, site, and operations views.
• You will provide leadership for involved project teams and across the broader organisation. Provides training materials and training for people joining the organisation. Acts as a coach for colleagues with less experience and helps them develop skills/expertise.
• You will champion continuous improvement initiates to reduce planned and unplanned downtime.
• You will ensure that the Utility Systems are compliant from a regulatory standpoint and provide audit support as needed.
• You will