Sterilization Process Specialist
hace 5 días
Stryker Professional Latin America, S. DE R.L. DE C.V. is seeking a skilled Sterilization Process Specialist to join our team in Mexico.
The estimated salary for this role is $120,000 - $180,000 per year, depending on experience and qualifications.
About the RoleWe are looking for a highly motivated and experienced Sterilization Process Specialist to lead our efforts in ensuring the compliance of products processed with Ethylene Oxide (EO) in accordance with relevant regulatory requirements and standards for Sterilization Process.
This is a unique opportunity to work in a fast-paced environment where you will have the chance to make a significant impact on the company's success.
Key Responsibilities- Develop and Validate Sterilization Processes: Ensure the ethylene oxide sterilization process is developed and validated in accordance with the ISO 11135 standard.
- Oversight and Control: Oversight of routine control of the ethylene oxide sterilization process to ensure the process is running in accordance the validated state and within the requirements of the procedures.
- Data Analysis and Trending: Interpreting sampling and monitoring data, applying statistical and analysis techniques, to determine control and trending. Identifies and initiates when to act.
- Validation and Re-qualification: Performs sterilization validations and re-qualifications in line with relevant BS EN ISO standards, actively participates in cycle developments and Validations for new products.
- Cross-functional Collaboration: Mentors and trains team and cross-functional groups as required (induction, GMP etc)
- Subject Matter Expert: Subject matter expert to local procedures, contribute to the development, maintenance and improvements of the policies and procedures to align to best practices, benchmarking against industry leads and regulatory requirements.
- Education: Bachelor's degree Microbiology or equivalent/ related subject required, with 4 years Microbiology related experience.
- Knowledge and Skills: Knowledge of EO Sterilization process, experienced with ISO 11135 required.
- Regulatory Experience: Experience in Quality/Regulatory Affairs environment required.
- Communication Skills: Proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
This is a full-time position with an estimated travel percentage of 10%.
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