Principal Maintenance Specialist, Packaging - CVRM (Holly Springs)

Genentech•Holly Springs, NC

2d•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). We're seeking a highly skilled Maintenance Specialist with direct Pharmaceutical Packaging 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.
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.
Specifically, experience with maintaining high performance pharmaceutical packaging lines.

Responsibilities

During the plant start-up project, be on the User Team and responsible for establishing the site’s maintenance program for Packaging equipment including procedures and training.
Support FATs for Packaging Equipment.
Flex to support other Holly Springs assets as well.
Partner and collaborate with partner organizations (Engineering and MSAT, Quality, Supply Chain, Technical Development, Regulatory, CMO, Strategy).
Perform a mix of remote and onsite work (first at the General Planner’s office, later at construction site/plant).
Transition to local full time on-site work once the site buildings are built and equipment delivered.
Provide in the field execution of maintenance activities on GMP assets, including planned preventative maintenance and repairs / troubleshooting.
Support troubleshooting of PLC/automation.
Adhere to applicable SOPs, comply with cGMP, and adhere 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.
Support Quality Record management through gathering information and providing SME.
Provide inputs to master data needed to support the maintenance program in SAP S4/HANA.
Understand controlled, classified environments, aseptic processing principles, and maintain associated qualifications for access.
Read and Understand P&IDs, work from Standard Operating Procedures (SOPs) and leverage basic computer skills using word processors, spreadsheets, databases, and email.