Consultant, EtO Sterilization Validation Engineer / Sterilization SME, Medical Device

Summary

Our client, an innovative medical device company, has engaged GForce Life Sciences to provide an experienced EtO Sterilization Validation Engineer / Sterilization Subject Matter Expert to support an urgent sterilization qualification project.

This consultant will be responsible for executing and/or leading IQ/OQ/PQ activities for an in-house tabletop ethylene oxide (EtO) sterilization system, advising on sterilization process validation strategies, and providing expertise related to ISO 11135 and ISO 10993-7 requirements.

The ideal candidate will be a hands-on expert capable of rapidly assessing the current state, identifying the most efficient path to compliance, and executing the required qualification with minimal oversight. The consultant should be able to provide any necessary validation tools, data loggers, sensors, and supporting documentation required to complete the project successfully.

Duties / Expectations of Role

• Assess and qualify an in-house tabletop EtO sterilization system.
• Lead and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.
• Develop qualification protocols, reports, and supporting validation documentation.
• Provide required qualification equipment, including data loggers, sensors, and monitoring tools.
• Evaluate sterilization process requirements and recommend compliant validation approaches.
• Support development of sterilization process validation strategies and documentation.
• Advise on ISO 11135 requirements for EtO sterilization validation.
• Advise on ISO 10993-7 requirements related to EO residuals.
• Provide recommendations regarding external sterilization alternatives when applicable.
• Deliver practical, streamlined solutions designed to meet compliance requirements while supporting aggressive project timelines.

Mandatory Requirements

• Bachelor’s degree in Engineering, Life Sciences, Quality, or a related technical field.
• Demonstrated experience with EtO sterilization systems and validation activities.
• Hands-on experience performing IQ/OQ/PQ qualifications.
• Strong knowledge of ISO 11135 sterilization requirements.
• Experience with sterilization process validation and protocol development.
• Familiarity with ISO 10993-7 and EO residual requirements.
• Ability to independently assess validation requirements and execute qualification activities.
• Ability to provide or source necessary validation instrumentation and qualification tools.

Nice to Have

• Experience qualifying tabletop EtO sterilizers.
• Medical device industry experience.
• Experience with preclinical product development programs.
• Experience supporting both in-house and contract sterilization operations.
• Consulting or project-based validation experience.

Term & Start

• Short-term consulting engagement.
• Estimated project duration: 1 day to 1 week.
• Start Date: ASAP.
• Project requires immediate support to meet urgent study timelines.
• Onsite support required in the San Francisco Bay Area / Alameda, CA region.
• Opportunity for future validation, sterilization, CQV, and quality projects as additional equipment and programs come online.
• Interview process: Resume review with expedited selection process.