Validation Engineer, Sterility Assurance
On-siteSunnyvale, California, United States
Job Summary
Manage routine Ethylene Oxide and radiation bioburden testing, coordinate with cross-functional teams, sterilizers, and laboratories, and drive projects to completion. Support the internal microbiology lab by following validated test methods, applying technical expertise to interpret results and investigate excursions, and conducting rigorous data analysis for single-use surgical instrument safety and efficacy. Oversee multiple projects requiring frequent communication between internal departments and outside services, provide technical support for sterilization release activities, and maintain bioburden procedures based on recognized standards. Conduct, review, and approve incident investigations while developing preventative actions for nonconformities. Assist with compliance audits for external facilities, implement projects per approved budget and schedule, and travel to supplier, sterilizer, or laboratory sites as needed.
Required Qualifications
- Must have microbiology lab experience or good working knowledge of sterility assurance test requirements
- Working knowledge of international medical device sterilization standards, such as ISO 11135 and ISO 11137
- Excellent verbal and written communication, teamwork, and interpersonal skills
- Self-starter with ability to take leadership in a fast-paced environment
- Able to prioritize and smoothly manage multiple tasks
- Able to manage project risk and timely escalate issues to senior management and team
- Hands-on engineering skills with the proven ability to work well in a team environment and drive individual projects
- Ability to focus, and attention to detail along with a strong track record of continuous improvement initiatives
- Well versed in MS Office Suite
- Ability to travel to supplier, sterilizer, or laboratory sites, including international travel
- Minimum Education: Bachelors of Science in Microbiology, Engineering, Life Science, Chemistry or technical equivalent
- Minimum of 4 years of professional experience with Ethylene oxide; radiation sterilization experience
Desired Qualifications
- Masters is preferred
- Minimum of 4 years of professional experience with Ethylene oxide; radiation sterilization experience is also desired
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