Principal Engineer - Device/Combination Product Sterilization

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

The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche!

The Opportunity

In this role, you will join a collaborative, cross-functional team dedicated to advancing life-saving healthcare solutions. You will serve as a technical expert in evaluating, validating, and optimizing sterilization processes for medical devices and combination products across the entire product lifecycle.

• Lead Sterilization Strategy: Evaluate and select appropriate sterilization methods (including radiation, heat, and chemical methods) for new primary containers, medical devices and combination products.

• Drive Validation & Requalification: Develop, execute, and author protocols and technical reports for sterilization process validation (IQ, OQ, PQ) and equipment qualification in compliance with cGMP and international standards.

• Enhance Quality & Compliance: Perform root cause analyses on process issues, implement continuous improvements, and manage risk, discrepancy, and change documentation within design control frameworks. Support internal audits, regulatory inspections, and notified body interactions by preparing responses and driving the closure of corrective actions

• Cross-Functional Collaboration: Partner closely with Commercial Marketing, Clinical Sciences, Quality, Regulatory Affairs, and Packaging and Pharmaceutical Development teams to seamlessly integrate sterilization guidance into device commercialization.

• External Partner Oversight: Oversee contract sterilizers and specialized testing laboratories to ensure project objectives and rigorous safety standards are met.

• Process & Method Innovation: Execute test-method validation projects using appropriate statistical tools, applying engineering and scientific principles to solve complex technical challenges.

Who You Are

You are a proactive, detail-oriented engineering or scientific professional who thrives in a collaborative environment. You bring an enterprise mindset, balancing technical rigor with innovative problem-solving to improve outcomes for patients worldwide.

• Education & Work Experience: Bachelor's, Master's, or Ph.D. degree in Engineering, Science, or a related technical discipline, paired with at least 5 years of total professional experience (including 3+ years in medical devices, biotech, healthcare, or pharmaceuticals).

• Sterilization Expertise: Familiarity with international sterilization standards (such as ISO 11135, ISO 14937, or ISO 11137).

• Design Control & GMP: Solid understanding of cGMP requirements, Good Documentation Practices (GDP), design verification/validation, and risk management tools (such as FMEA, ISO 14971); working knowledge of ISO 13485

• Collaborative Mindset: Strong written and verbal communication skills with a proven ability to partner effectively across cross-functional teams and external vendor networks.

Preferred:

• Practical experience with electron beam, ethylene oxide, or steam sterilization.

• Working knowledge of microbiological testing, biocompatibility and associated international standards(ISO11138, ISO14161, ISO10993) required to support sterilization process validation.

• Proven track record of working effectively in a matrix organization with a highly cross-functional (e.g., device development, regulatory, clinical, quality, and program management) and collaborative) environment is very desirable.

Relocation benefits are available for this job posting.

The expected salary range for this position based on the primary location of South San Francisco, CA is $109,500 - $203,300. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.