Lead Sterilization Engineer, Medical Devices & Combo Products

Genentech, Inc.; South San Francisco (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

Genentech in South San Francisco is seeking a Sterilization Engineering expert to evaluate, validate, and optimize sterilization processes for medical devices and combination products across the product lifecycle.

You will lead strategy for sterilization methods (radiation, heat, chemical), develop validation protocols (IQ/OQ/PQ) and device qualifications, and collaborate with Quality, Regulatory Affairs, and Manufacturing to ensure compliant, safe products and timely project execution.

Qualifications

Responsibilities

• Evaluate, validate, and optimize sterilization processes for medical devices and combination products across the product lifecycle.
• Lead strategy for sterilization methods (radiation, heat, chemical).
• Develop validation protocols (IQ/OQ/PQ) and device qualifications, and partner with Quality, Regulatory Affairs, and Manufacturing to ensure compliant, safe products and timely project execution.

Skills

Sterilization engineering

Validation protocols

Job description

Genentech in South San Francisco is seeking a Sterilization Engineering expert to evaluate, validate, and optimize sterilization processes for medical devices and combination products across the product lifecycle.

You will lead strategy for sterilization methods (radiation, heat, chemical), develop validation protocols (IQ/OQ/PQ) and device qualifications, and collaborate with Quality, Regulatory Affairs, and Manufacturing to ensure compliant, safe products and timely project execution.