Principal Maintenance Specialist, Assembly - CVRM (Holly Springs)

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.

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.

• •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 need to Read and Understand P&lDs, work from Standard Operating Procedures (SOPs) and have basic computer skills using word processors, spreadsheets, databases, and email.
• •You will provide inputs to master data needed to support the maintenance program in SAP S4/HANA.
• •You will support Quality Record management through gathering information and providing SME. Proficient in Quality Management System(s).
• •You will need to understand controlled, classified environments, aseptic processing principles, and maintain associated

• •This role will have a defined work shift but will require flexible working hours including overtime or on-call (sometimes in an emergency situations) to meet business needs.
• •May work in the clean room environment that requires gowning in the form of 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 which includes lifting up to 35 lbs, navigating stairs/ladders/scaffolding, transporting equipment to the location of instruments, and working away from a desk for the majority of working shift.
• •Be able to work extensive hours while standing

Link to Benefits