Principal Plant Engineer - HVAC, CVRM

Genentech•Cary, NC

11d•$95,200 - $176,800•Hybrid

About 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.

Requirements

Bachelor’s degree in engineering or life sciences and 8+ years of work experience in the pharmaceutical or related industry with direct experience in a cGMP regulated environment OR Associate’s degree in engineering or life sciences and 10+ years of experience in the pharmaceutical or related industry with direct experience in a cGMP regulated environment.
Ability to organize and solve complex, unique or unprecedented problems through the regular use of ingenuity and innovation; consistently demonstrating courage and drive to ensure optimal business results.
Updated knowledge of cGMP’s, Health Authority regulations, and Quality Systems.
Experience with collaborators, regulatory agencies, and vendors inside and outside the company including coordination across organizational lines, including advising and influencing senior management on advanced technical matters.
Utilizes an established network for technical issues within the company and the industry.
Strong organizational and interpersonal skills: can get things done in a way that optimizes results, strengthens internal and external relationships, and with consideration of resources.
Coaches others.
Experience with process control and building automation systems.
Experience of Fire Suppression and monitoring systems
Thorough understanding of Electrical Systems.

Nice To Haves

Experience with Propane, CO2, and Ammonia systems is preferred but not a requirement.

Responsibilities

Establishing the site’s foundational asset management program for HVAC-R and plant utility systems.
Providing 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.
Providing strategic and tactical leadership to ensure that the facility's HVAC systems operate with maximum reliability and in strict compliance with cGMP standards.
Driving optimal greenfield facility and operations design towards high manufacturing efficiency and quality in line with product and regulatory requirements.
Overseeing HVAC/R and Cleanroom Performance Testing contract services, to ensure maintenance needs are met and evaluate vendors or service contractor performance.
Owning utility, HVAC/R, electrical, and control systems serving the manufacturing site and ensuring a state of continuous compliance and audit readiness through the application of good engineering practices and troubleshooting methodologies.
Developing and optimizing a reliability program for HVAC/R equipment and site infrastructure and proactively managing instrumentation/equipment obsolescence and improvement projects.
Providing leadership for involved project teams and across the broader organisation.
Championing continuous improvement initiates to reduce planned and unplanned downtime.
Ensuring that the Utility Systems are compliant from a regulatory standpoint and provide audit support as needed.
Developing and owning the HEPA Program.
Being POC for HVAC related QMS Records. (Change Controls, Deviations, etc)
Being responsible for compliance with EPA Section 608 as applicable