Principal Maintenance Specialist, Assembly - CVRM (Holly Springs)

Genentech; Holly Springs (NC); On-site; USD 81,400 - 151,200; Full time

Job summary

A global biopharmaceutical company in Holly Springs, North Carolina, is seeking a Maintenance Specialist to oversee maintenance operations for medical device assembly equipment. The ideal candidate will have over seven years of experience in an industrial setting, with a strong mechanical aptitude and ability to tackle complex challenges. Responsibilities include troubleshooting, documentation in SAP, and maintaining compliance with quality standards. The role requires working flexible hours and may involve travel during the project phase.

Qualifications

• 7+ years of related work experience in an industrial/manufacturing setting.
• Experience with maintaining a medical device assembly line.
• Familiarity with cGMPs and Health Authority regulations.

Responsibilities

• Lead troubleshooting and issue resolution for mechanical challenges.
• Perform maintenance on GMP assets including repairs and troubleshooting.
• Create and facilitate continuing education for maintenance staff.

Skills

Mechanical aptitude

Problem-solving

Project management

Communication skills

Digital tools proficiency

Education

High School diploma or equivalent

A.A., A.S., A.A.S., or Trade School Certificate

Job description

The Position

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).

The Opportunity

We’re 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 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.

What You’ll Do

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 Assembly equipment including procedures and training. You will also be responsible for supporting FAT for Device Assembly Equipment. While this role is focused on Assembly, 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

• Provide in‑field execution of maintenance activities on GMP assets, including both planned preventative maintenance and repairs/troubleshooting. Supporting troubleshooting of PLC/automation is expected while adhering to applicable SOPs, cGMP, and a range of safety standards.
• Perform timely, detailed documentation following Good Documentation Practices in electronic (e.g., SAP) and paper‑based systems.
• Create and facilitate continuing education for the maintenance staff to increase technical skills through formal and informal training, coaching, and mentorship.
• Assist with identification of spare parts and BOM improvements to improve service delivery and reduce equipment downtime.
• Read and understand P&lDs, work from Standard Operating Procedures (SOPs), and possess basic computer skills using word processors, spreadsheets, databases, and email.
• Provide inputs to master data needed to support the maintenance program in SAP S4/HANA.
• Support Quality Record management through gathering information and providing SME; proficient in Quality Management System(s).
• Understand controlled, classified environments, aseptic processing principles, and maintain associated qualifications for access.

Who You Are

• High School diploma or equivalent with 7+ years of related work experience in an industrial/manufacturing setting with demonstrated strong mechanical aptitude. 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 a medical device assembly line.
• Ability to organize and solve complex, unique, or unprecedented problems through regular use of ingenuity and innovation; consistently demonstrating courage and drive to ensure optimal business results.
• Proficient in using AI and other digital tools to solve complex challenges.
• Familiarity with cGMPs, Health Authority regulations, and Quality Systems.
• Strong interpersonal, communication (written and verbal), project management, and time management skills.

Work Environment/Safety Considerations

• Defined work shift but requires flexible working hours, including overtime or on‑call, to meet business needs.
• May work in a clean room environment with gowning in hospital scrubs, bunny suits, gloves, and steel‑toe boots.
• Potential to work near hazardous materials, chemicals, and equipment as per company safety procedures and guidelines.
• Active role includes lifting up to 35 lbs, navigating stairs/ladders/scaffolding, transporting equipment to instrument locations, and working away from a desk for the majority of the shift.
• Expect to work extensive hours while standing.

The expected salary range for this position based on the primary location for this position of Holly Springs, North Carolina is $81,400 - $151,200. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job‑related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

Link to Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company’s policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disability status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.