Principal Maintenance Specialist, Assembly - CVRM (Holly Springs)

Roche•South San Francisco, CA

4d•Onsite

About 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: 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 qualifications for access.

Requirements

High School diploma or equivalent with 7+ years of related work experience in an industrial / manufacturing setting with demonstrated strong mechanical aptitude
Specifically, experience with maintaining a medical device assembly line
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
Proficient 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

Nice To Haves

An A.A., A.S., A.A.S., or Trade School Certificate is preferred with 5+ years of related work experience

Responsibilities

Leading troubleshooting and issue resolution for highly complex mechanical challenges
Providing coaching / mentorship / training of other Facilities personnel
Serve as owners or functional representatives on projects
Support the maintenance of process and utility equipment supporting production in Holly Springs
Establishing the site’s maintenance program for Assembly equipment including procedures and training
Supporting FAT for Device Assembly Equipment
Provide in the field execution of maintenance activities on GMP assets
Perform planned preventative maintenance and repairs / troubleshooting
Supporting troubleshooting of PLC/automation
Adhering to applicable SOPs, complying with cGMP, and adhering to Federal, State, Local, and Genentech 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
Provide assistance 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 have 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