# Principal/Senior Principal Validation Engineer at Genentech

- Company: Genentech
- What the company does: Genentech discovers, develops, manufactures and commercializes treatments for patients with serious and life-threatening medical conditions. Backed by North Carolina Biotechnology Center.
- Company website: https://gene.com
- Type: Startups
- Level: Principal and up
- Location: Holly Springs
- Work setup: On-site
- Pay: $95K to $176K base salary per year (USD)
- Posted: 2026-09-10
- Apply by: 2026-10-25
- Apply: https://roche.wd3.myworkdayjobs.com/en-US/ROG-A2O-GENE/job/Holly-Springs/Principal-Senior-Principal-Validation-Engineer_202609-123314-1
- Page: https://www.1752.vc/careers/jobs/genentech-principal-senior-principal-validation-engineer/

## 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

