Note: The job is a remote job and is open to candidates in USA. Intellectt Inc is seeking a Sterilization Consultant with deep expertise in medical device sterilization processes. This role involves providing technical guidance on sterilization processes, evaluating suppliers, and ensuring compliance and validation of sterilization methods.
Responsibilities
- Serve as a Sterilization Subject Matter Expert (SME) for medical device products
- Provide technical guidance on Ethylene Oxide (EtO/EO) sterilization processes
- Support evaluation and qualification of alternate sterilization suppliers
- Review existing sterilization processes, systems, and documentation for adequacy and compliance
- Lead and support sterilization validation activities, including protocol development, execution, and review
- Collaborate with suppliers, engineering teams, quality teams, and project stakeholders
- Manage project activities, timelines, and technical deliverables
Skills
- Extensive 8-10 years of experience as a sterilization SME within the medical device industry
- Strong expertise in Ethylene Oxide (EtO) sterilization
- Demonstrated experience with sterilization validation and regulatory requirements
- Experience supporting supplier transitions, sterilization qualification, or process validation activities
- Strong communication and project management skills
- Ability to work remotely; candidates located in EST or CST time zones preferred
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