Genentech discovers, develops, manufactures and commercializes treatments for patients with serious and life-threatening medical conditions. Backed by North Carolina Biotechnology Center.
About the role
Reporting to the Head of Validation, the Principal/Senior Principal Validation Engineer serves as the primary technical expert for establishing and executing validation strategies across high-speed pre-filled syringe (PFS) assembly, labeling, traying, automated cartoning, case packing, and associated facilities and utilities.
What they're looking for
- You have a BS/MS in chemical, biochemical engineering, or related field/experience, with a minimum of 5 -7 years (Principal) and 8 -11 years (Senior Principal) experience in drug product fill finish/packaging, Engineering, Manufacturing, or Technical Services
- You have experience in the pharma/biotech industry
- You have hands-on experience in the design, selection, installation, and validation of equipment used in assembly and packaging of autoinjectors or pen lines
- You have knowledge of cGMPs or equivalent regulations, experience working in a regulated environment, and a strong understanding of the regulatory requirements
- You have working knowledge of visual inspections, assembly, and packaging, equipment qualification in a regulated environment
- You have experience in managing equipment and process related projects, including commissioning and qualification, performance qualifications, PPQs, new product introduction, and technology transfers
More about this role
Welcome to Holly Springs, North Carolina— home to Genentech's largest-ever investment with an ambitious goal to be a fully connected Plant of the Future. This is where next-generation technology, capability, digital connectivity and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing. This will include Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products.
The facility's core is defined by innovation - leveraging advanced automation, robotics, digital tools, real-time data analytics, and simple, streamlined processes to produce the highest quality medicines. This plant will not only meet today’s demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines but is a strategic commitment to be scalable with this portfolio, which serves one of the largest patient populations in the world. This is a fast-paced, highly entrepreneurial environment with a high-level of accountability from the site team to launch operations in 2028.
Are you a problem-solver and change agent who thrives in a High-Performing Team environment, eager to tackle the...
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