Senior Sterilization Engineer - Medical Devices & Combo Products

Genentech; South San Francisco (CA); On-site; USD 110,000 - 203,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Genentech, a Roche subsidiary 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 partner with Quality, Regulatory Affairs, and Manufacturing to ensure compliant, safe products and timely project

Qualifications

• Bachelor's or higher in engineering/science with 5+ years in the field.
• Knowledge of ISO 11135/14937/11137 sterilization standards.
• Experience with design controls, GDP, and risk management tools.

Responsibilities

• 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 control frameworks. Support internal audits, regulatory inspections, and notified body interactions by preparing responses and driving the closure of corrective actions
• Cross-Functional Collaboration: Partner closely with Commercial Marketing, Clinical Sciences, Quality, Regulatory Affairs, and Packaging and Pharmaceutical Development teams to seamlessly integrate sterilization guidance into device commercialization.
• External Partner Oversight: Oversee contract sterilizers and specialized testing laboratories to ensure project objectives and rigorous safety standards are met.
• Process & Method Innovation: Execute test-method validation projects using appropriate statistical tools, applying engineering and scientific principles to solve complex technical challenges.

Skills

Sterilization expertise

Validation & qualification

cGMP & ISO standards

Cross-functional collaboration

Statistical tools

Education

Bachelor's, Master's, or Ph.D. in Engineering/Science

5+ years total experience including 3+ in medical devices/biotech/pharma

Job description

Genentech, a Roche subsidiary 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 partner with Quality, Regulatory Affairs, and Manufacturing to ensure compliant, safe products and timely project