Lead Sterilization Engineer – Medical Devices

NCBiotech; King (NC); On-site; USD 110,000 - 203,000; Full time

Benefits offered by this job

Relocation benefits

Job summary

Genentech seeks an experienced engineer/scientist to lead sterilization strategy and validation across medical devices and combination products, ensuring compliance with cGMP and international standards.

The role collaborates across commercial, clinical, quality, regulatory, and development teams, oversees external contract sterilizers, and drives process innovation to support safe, high-quality healthcare solutions.

Qualifications

• Bachelor's, Master's, or Ph.D. in Engineering, Science, or related discipline with at least 5 years total professional experience (including 3+ years in medical devices, biotech, healthcare, or pharmaceuticals).
• Familiarity with international sterilization standards (ISO 11135, ISO 14937, ISO 11137).
• Solid understanding of cGMP requirements, Good Documentation Practices (GDP), design verification/validation, and risk management tools (ISO 14971); working knowledge of ISO 13485.

Responsibilities

• Lead sterilization strategy and evaluate methods for new products.
• Drive validation, requalification, IQ/OQ/PQ, and equipment qualification per cgmp and standards.
• Support audits, regulatory inspections, and corrective actions within design control frameworks.
• Collaborate with cross-functional teams to integrate sterilization guidance into device commercialization.

Skills

Sterilization expertise

Design control & GMP

Cross-functional collaboration

Statistical analysis

Regulatory compliance

ISO standards knowledge

Education

Bachelor's/Master's/PhD in Engineering/Science

Tools

GDP documentation practices

ISO 13485 knowledge

FMEA experience

Job description

Genentech seeks an experienced engineer/scientist to lead sterilization strategy and validation across medical devices and combination products, ensuring compliance with cGMP and international standards.

The role collaborates across commercial, clinical, quality, regulatory, and development teams, oversees external contract sterilizers, and drives process innovation to support safe, high-quality healthcare solutions.