Principal Engineer - Device/Combination Product Sterilization

About the role

Roche is hiring a Principal Engineer for its sterilization function in South San Francisco. You will join a cross-functional team and act as technical expert in evaluating, validating and optimizing sterilization processes for medical devices and combination products across their entire product lifecycle.

Key responsibilities

• Evaluate and select appropriate sterilization methods (radiation, heat, chemical) for new primary containers, medical devices and combination products
• Develop, execute and author protocols and technical reports for sterilization validation (IQ, OQ, PQ) and equipment qualification in line with cGMP and international standards
• Perform root cause analyses, drive continuous improvement and manage risk, discrepancy and change documentation within design control
• Support internal audits, regulatory inspections and notified body interactions by preparing responses and closing corrective actions
• Partner with Commercial Marketing, Clinical Sciences, Quality, Regulatory Affairs and Packaging and Pharmaceutical Development teams
• Oversee contract sterilizers and specialized testing laboratories
• Run test-method validation projects using statistical tools

Required profile

• Bachelor's, Master's or Ph.D. in Engineering, Science or a related technical discipline
• At least 5 years of total professional experience, including 3+ years in medical devices, biotech, healthcare or pharmaceuticals
• Familiarity with international sterilization standards such as ISO 11135, ISO 14937 or ISO 11137
• Solid understanding of cGMP, GDP, design verification/validation and risk management tools (FMEA, ISO 14971); working knowledge of ISO 13485
• Strong written and verbal communication and collaboration across cross-functional teams and vendors
• Preferred: practical experience with electron beam, ethylene oxide or steam sterilization, and working knowledge of microbiological testing, biocompatibility and standards such as ISO 11138, ISO 14161 and ISO 10993
• Experience in a matrix organization is very desirable

What we offer

• Expected salary range of $109,500 - $203,300 depending on experience, qualifications and location
• A discretionary annual bonus may be available
• Relocation benefits are available