Principal Maintenance Specialist, Compounding and Filling - CVRM (Holly Springs)

Genentech•Holly Springs, NC

13d•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. The Opportunity We're seeking a highly skilled Maintenance Specialist with direct Pharmaceutical compounding and filling Equipment experience who will be accountable for leading troubleshooting and issue resolution for highly complex mechanical challenges, providing coaching / mentorship / training of other Facilities personnel, and serve as owners or functional representatives on projects. In addition, they are accountable to support the maintenance of process and utility equipment supporting production in Holly Springs. Pre-Startup: During the plant start-up project you will be on the User Team and be responsible for establishing the site’s maintenance program for compounding and filling equipment including procedures and training. You will also be responsible for supporting FATs for compounding and filling Equipment. While this role is focused on compounding and filling, you are expected to be able to flex to support other Holly Springs assets as well. To accomplish this, you will partner and collaborate with our partner organizations (Engineering and MSAT, Quality, Supply Chain, Technical Development, Regulatory, CMO, Strategy). 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 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 perform 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 support Quality Record management through gathering information and providing SME input. Proficient in Quality Management System(s). You will provide inputs to master data needed to support the maintenance program in SAP S4/HANA. You will need to understand controlled, classified environments, aseptic processing principles, and maintain associated qualifications for access. You will read and understand P&lDs, work from Standard Operating Procedures (SOPs) and leverage basic computer skills using word processors, spreadsheets, databases, and email.

Requirements

High School diploma or equivalent with 7+ years of related work experience in an industrial / manufacturing setting with demonstrated strong mechanical aptitude.
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.
Proficiency in using AI and other digital tools to solve complex challenges.
Familiarity with cGMP's, Health Authority regulations, and Quality Systems.
Strong interpersonal, communication (written and verbal), project management, and time management skills.
Basic computer skills using word processors, spreadsheets, databases, and email.

Nice To Haves

An A.A., A.S., A.A.S., or Trade School Certificate is preferred with 5+ years of related work experience.
Specifically, experience with maintaining high performance pharmaceutical compounding and filling lines.

Responsibilities

Leading troubleshooting and issue resolution for highly complex mechanical challenges.
Providing coaching, mentorship, and training of other Facilities personnel.
Serving as owners or functional representatives on projects.
Supporting the maintenance of process and utility equipment.
Establishing the site’s maintenance program for compounding and filling equipment including procedures and training during plant start-up.
Supporting FATs for compounding and filling Equipment.
Providing in the field execution of maintenance activities on GMP assets, including planned preventative maintenance and repairs/troubleshooting.
Supporting troubleshooting of PLC/automation.
Performing timely detailed documentation following Good Documentation Practices in electronic (e.g. SAP) and paper based systems.
Creating and facilitating continuing education for the maintenance staff to increase technical skills through formal and informal training, coaching and mentorship.
Providing assistance with identification of spare parts and BOM improvements to improve service delivery and reduce equipment downtime.
Supporting Quality Record management through gathering information and providing SME input.
Providing inputs to master data needed to support the maintenance program in SAP S4/HANA.
Understanding controlled, classified environments, aseptic processing principles, and maintaining associated qualifications for access.
Reading and understanding P&lDs, working from Standard Operating Procedures (SOPs).