Principal Maintenance Specialist, Assembly - CVRM (Holly Springs)

Genentech•Holly Springs, NC

2d•Hybrid

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). 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.

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 a medical device assembly line.

Responsibilities

Leading troubleshooting and issue resolution for highly complex mechanical challenges.
Providing coaching / mentorship / training of other Facilities personnel.
Serving as owners or functional representatives on projects.
Supporting 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.
Flexing to support other Holly Springs assets.
Partnering and collaborating with partner organizations (Engineering and MSAT, Quality, Supply Chain, Technical Development, Regulatory, CMO, Strategy).
Providing in the field execution of maintenance activities on GMP assets, including 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.
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.
Assisting with identification of spare parts and BOM improvements to improve service delivery and reduce equipment downtime.
Reading and understanding P&IDs.
Working from Standard Operating Procedures (SOPs).
Providing inputs to master data needed to support the maintenance program in SAP S4/HANA.
Supporting Quality Record management through gathering information and providing SME.
Understanding controlled, classified environments, aseptic processing principles, and maintaining associated qualifications for access.