Lead Sterilization Engineer, Medical Devices & Combinations

Genentech; King of Prussia (PA); On-site; USD 110,000 - 203,000; Full time

Benefits offered by this job

Relocation benefits

Job summary

Genentech is seeking an experienced engineer/scientist to lead sterilization strategy for medical devices and combination products. You will evaluate methods, develop IQ/OQ/PQ protocols, and drive validation activities across the product lifecycle.

Responsibilities include ensuring quality and regulatory readiness, partnering with Quality, Regulatory, and Development teams, and managing external labs to uphold safety standards. A strong background in ISO/GMP and design controls is required.

Qualifications

• Bachelor’s, Master’s, or Ph.D. in Engineering, Science, or related field.
• ≥5 years total professional experience (≥3 years in medical devices/biotech/pharma).
• Familiarity with ISO/IEC sterilization standards and cGMP practices.
• Knowledge of design control, GDP, risk management tools and ISO 13485.

Responsibilities

• Lead sterilization strategy for containers, devices, and combination products.
• Develop and execute validation/qualification protocols (IQ/OQ/PQ) and equipment qualification.
• Enhance quality, manage risk, and support regulatory inspections and corrective actions.
• Collaborate with cross-functional teams to integrate sterilization guidance into device commercialization.
• Oversee contract sterilizers and external labs to meet project objectives and safety standards.
• Execute test-method validation projects using appropriate statistical tools.

Skills

Sterilization

Cross-functional

Quality systems

Regulatory

Statistical methods

Education

Engineering/Science degree

Job description

Genentech is seeking an experienced engineer/scientist to lead sterilization strategy for medical devices and combination products. You will evaluate methods, develop IQ/OQ/PQ protocols, and drive validation activities across the product lifecycle.

Responsibilities include ensuring quality and regulatory readiness, partnering with Quality, Regulatory, and Development teams, and managing external labs to uphold safety standards. A strong background in ISO/GMP and design controls is required.