Principal Maintenance Specialist, Assembly - CVRM (Holly Springs)

Pharma Technical Manufacturing (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. 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). Opportunity We are seeking a highly skilled Maintenance Specialist with direct Medical Device Assembly 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 owner or functional representative on projects. In addition, you will support the maintenance of process and utility equipment supporting production in Holly Springs. Responsibilities Pre‑Startup: Establish the site’s maintenance program for Assembly equipment including procedures and training; support FAT for Device Assembly Equipment; work as part of the User Team; collaborate with Engineering, MSAT, Quality, Supply Chain, Technical Development, Regulatory, CMO, Strategy; perform remote and onsite work during construction; travel up to 30% during project phase. Post‑Startup: Execute maintenance activities on GMP assets including planned preventive maintenance, repairs, and troubleshooting; support PLC/automation troubleshooting; adhere to SOPs, cGMP, Federal, State, Local, and Genentech safety standards; document maintenance in SAP S4/HANA and paper systems; facilitate continuing education for maintenance staff via formal and informal training, coaching, and mentorship; assist in spare parts identification and BOM improvements; read & understand P&lDs; work from SOPs; use basic computer skills with word processors, spreadsheets, databases, and email. Qualifications High School diploma or equivalent with 7+ years of related experience in an industrial/manufacturing setting, strong mechanical aptitude. A.A., A.S., A.A.S., or Trade School Certificate preferred with 5+ years of related experience. Experience maintaining a medical device assembly line. Strong problem solving with ingenuity and innovation; effective communication (written and verbal), project management, time management, and interpersonal skills. Proficiency with AI and other digital tools for complex challenges. Familiarity with cGMP, Health Authority regulations, and quality systems. Work Environment / Safety Considerations The role will have a defined shift with flexible hours, overtime, and on‑call duties. Working in clean room environments requiring gowning (hospital scrubs, bunny suits, gloves, steel toe boots) and exposure to hazardous materials, chemicals, and equipment. Responsibilities include lifting up to 35 lbs, navigating stairs/ladders/scaffolding, transporting equipment, and standing for extended periods. Salary and Benefits Salary range: $81,400 - $151,200 (based on experience, level, qualifications, geographic location, and other factors). Discretionary annual bonus may be available. Full benefits package details are available upon request. Who We Are Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life‑threatening diseases. To solve the world’s most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. EEO Statement Genentech is an equal opportunity employer. We employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. Our policy prohibits unlawful discrimination, including discrimination on the basis of Protected Veteran status, individuals with disabilities, and consistent with all federal, state, and local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing the Accommodations for Applicants form. #J-18808-Ljbffr F. Hoffmann-La Roche AG