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
In this role, you will join a collaborative, cross-functional team dedicated to advancing life-saving healthcare solutions. You will serve as a technical expert in evaluating, validating, and optimizing sterilization processes for medical devices and combination products across the entire product lifecycle. Lead Sterilization Strategy: Evaluate and select appropriate sterilization methods (including radiation, heat, and chemical methods) for new primary containers, medical devices and combination products.
What they're looking for
- You are a proactive, detail-oriented engineering or scientific professional who thrives in a collaborative environment. You bring an enterprise mindset, balancing technical rigor with innovative problem-solving to improve outcomes for patients worldwide
- Sterilization Expertise: Familiarity with international sterilization standards (such as ISO 11135, ISO 14937, or ISO 11137)
- Design Control & GMP: Solid understanding of cGMP requirements, Good Documentation Practices (GDP), design verification/validation, and risk management tools (such as FMEA, ISO 14971), working knowledge of ISO 13485
- Collaborative Mindset: Strong written and verbal communication skills with a proven ability to partner effectively across cross-functional teams and external vendor networks
More about this role
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche!
In this role, you will join a collaborative, cross-functional team dedicated to advancing life-saving healthcare solutions. You will serve as a technical expert in evaluating, validating, and optimizing sterilization processes for medical devices and combination products across the entire product lifecycle.
Lead Sterilization Strategy: Evaluate and select appropriate sterilization methods (including radiation, heat, and chemical methods) for new primary containers, medical devices and combination products.
Drive Validation & Requalification: Develop, execute, and author protocols and technical reports for sterilization process validation (IQ, OQ, PQ) and equipment qualification in compliance with cGMP and international standards.
Enhance Quality & Compliance: Perform root cause analyses on process issues, implement continuous improvements, and manage risk, discrepancy, and change documentation within design...
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