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
As a Process Validation Engineer in our Manufacturing Sciences and Technology (MSAT) group, you will support cross-functional process validation strategies, lead regulatory documentation efforts, and ensure compliance across site-specific initiatives. This role serves as a structured professional growth pathway where you will gain hands-on exposure to core validation methodologies alongside senior engineers while driving continuous process improvements.
What they're looking for
- You hold a Bachelor’s degree in Chemical Engineering, Bioengineering, Life Sciences, or a related discipline with 4–6 years of relevant industry experience, OR a Master’s degree with 2–4 years of experience
- You possess practical experience with process validation concepts, technical writing, regulatory submission support, and Quality Systems within a cGMP biopharmaceutical manufacturing environment
- You have a strong foundational understanding of biopharmaceutical unit operations and process engineering principles
- You bring exceptional attention to detail with demonstrated skill in technical formatting, compliance checks, and verifying raw source data
- You are a strong communicator and proactive problem-solver who thrives when collaborating with cross-functional and global network partners
More about this role
Oceanside Operations (OCN) is a drug substance manufacturing organization dedicated to the reliable production of Roche’s commercial portfolio and pipeline products. Every year, OCN delivers millions of units of life-saving medicines to patients around the globe by leveraging its two integrated value streams: Stainless Steel and Single-Use production systems.
As a Process Validation Engineer in our Manufacturing Sciences and Technology (MSAT) group, you will support cross-functional process validation strategies, lead regulatory documentation efforts, and ensure compliance across site-specific initiatives. This role serves as a structured professional growth pathway where you will gain hands-on exposure to core validation methodologies alongside senior engineers while driving continuous process improvements.
- Author, edit, and execute Process Validation (PV) protocols, execution reports, and regulatory deliverables (such as PPQ OneDoc, PAS, and IMA) in accordance with cGMP standards.
- Perform rigorous compliance and data-integrity checks on draft validation documents to ensure summary findings and data tables strictly align with raw supporting data.
- Collaborate with the PV...
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