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Senior Microbiologist

hace 1 mes

Tijuana, Baja California, México Stryker Professional Latin America, S. DE R.L. DE C.V. A tiempo completo
Job Summary

The Staff Microbiologist will be primarily responsible for ensuring the compliance of products processed with Ethylene Oxide (EO) in Stryker are in accordance with relevant regulatory requirements and standards for Sterilization Process.

The senior microbiologist will oversee and ensure the process of sterilization processing is performed and sustained in compliance through testing, monitoring and validation of EO processes and associated utilities.

Responsibilities and Functions

Ensure the ethylene oxide sterilization process is developed and validated in accordance with the ISO 11135 standard.
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.
Interpreting sampling and monitoring data, applying statistical and analysis techniques, to determine control and trending. Identifies and initiates when to act. Leads NC and CAPA generation and resolution related to the Quality System or Process deviations.
Performs sterilization validations and re-qualifications in line with relevant BS EN ISO standards, actively participates in cycle developments and Validations for new products. Ensure compliance of new products to sites sterility standards. Ensure successful integration of products into validated processes.
Performing sampling for validations and re-qualifications as required. Review of validation files for compliance. Interact with Supplier quality team with respect to vendor sterility topics. Performs processing release review, interpreting data and trends.
Continually identifies opportunity for stabilization of trends, statistical control of processes to allow cost saving. Mentors and trains team and cross functional groups as required (induction, GMP etc)
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.
Coach, mentor and train other functions in area of EO Processing and monitoring. Demonstrate technical supervisory capabilities and leads projects to completion. Demonstrates knowledge of the business processes and products across multiples sites.

Requirements

Bachelor's degree Microbiology or equivalent/ related subject required, with 4 years Microbiology related experience.
Master of Microbiology or equivalent related subject required.
Knowledge of EO Sterilization process, experienced with ISO 11135 required.
Knowledge of 21 CFR Part 820 and ISO 13485 highly preferred.
Experience in Quality/Regulatory Affairs environment required.
Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.
Thorough knowledge and understanding of US and International Medical Device Regulations and standards in area of expertise (Microbiology)
Proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.

Travel Percentage

10%