Lead Sterilization Engineer - Device & Combination

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

Benefits offered by this job

Relocation benefits available

Job summary

Genentech, a member of the Roche family, is seeking an experienced engineer to advance sterilization processes for medical devices and combination products in a cross-functional setting.

You will lead sterilization strategy, develop validation protocols (IQ/OQ/PQ) and equipment qualification, and ensure compliance with cGMP, GDP, ISO standards while partnering with QA, Regulatory, and Development teams to bring safer products to patients.

Qualifications

• Bachelor’s, Master’s, or Ph.D. in Engineering or Science with 5+ years total experience.
• Sterilization expertise with ISO 11135/14937/11137 familiarity.
• Solid understanding of cGMP, GDP, design verification/validation, and ISO 14971 risk management.

Responsibilities

• Lead sterilization strategy selection for new containers and devices.
• Develop and execute validation protocols (IQ/OQ/PQ) and equipment qualification.
• Perform root cause analyses and drive corrective actions within design controls.
• Collaborate cross-functionally with marketing, clinical, QA, regulatory, and packaging teams.
• Oversee contract sterilizers and testing labs to meet project objectives.

Skills

Sterilization

Validation & Verification

Quality & Compliance

Cross-Functional Collaboration

Process Improvement

Education

Bachelor/Master/PhD in Engineering or Science

Tools

cGMP

GDP

FMEA

ISO 13485

ISO 14971

Job description

Genentech, a member of the Roche family, is seeking an experienced engineer to advance sterilization processes for medical devices and combination products in a cross-functional setting.

You will lead sterilization strategy, develop validation protocols (IQ/OQ/PQ) and equipment qualification, and ensure compliance with cGMP, GDP, ISO standards while partnering with QA, Regulatory, and Development teams to bring safer products to patients.