Senior Sterilization Engineer - Devices & Combo Products

Genentech; San Francisco (CA); Hybrid; USD 110,000 - 203,000; Full time

Benefits offered by this job

Relocation benefits

Discretionary annual bonus

Job summary

Genentech, located in South San Francisco, seeks an experienced engineer/scientist to evaluate, validate, and optimize sterilization processes for medical devices and combination products across the lifecycle.

You will partner with cross-functional teams to integrate sterilization guidance into device commercialization and support external vendor oversight. Relocation benefits are available; a discretionary annual bonus may apply.

Qualifications

• Bachelor's, Master's, or Ph.D. in Engineering, Science, or related field with 5+ years total experience.
• Familiarity with ISO 11135/14937/11137 sterilization standards and cGMP requirements.
• Experience with design control, GDP, risk management tools (ISO 14971) and ISO 13485.

Responsibilities

• Lead sterilization strategy across primary containers, medical devices, and combination products.
• Drive validation and requalification for sterilization processes (IQ/OQ/PQ) and equipment qualification.
• Enhance quality, compliance, and risk management; support audits and regulatory inspections.

Skills

Sterilization expertise

Cross-functional collaboration

Quality & compliance

ISO standards knowledge

Education

Bachelor's degree

Master's degree

Ph.D.

Job description

Genentech, located in South San Francisco, seeks an experienced engineer/scientist to evaluate, validate, and optimize sterilization processes for medical devices and combination products across the lifecycle.

You will partner with cross-functional teams to integrate sterilization guidance into device commercialization and support external vendor oversight. Relocation benefits are available; a discretionary annual bonus may apply.