Microbiology Specialist
hace 2 meses
**Role Overview**
Boston Scientific is seeking a skilled Microbiology Engineer to join their team in Cartago, CR. This individual will be responsible for establishing and maintaining a robust quality system in compliance with applicable regulations. The successful candidate will have a unique opportunity to be part of a cross-functional team to develop and implement procedures related to Microbiology and Sterilization.
**Key Responsibilities**
- Supports the Controlled Environment Rooms and critical systems qualification processes.
- Establish and maintain the monitoring program of controlled environments in the new Cartago West site.
- Establish and maintain the finished goods microbiological testing program.
- Lead the establishment of Microbiology Lab procedures in alignment with corporate requirements and international regulations.
- Oversee the validation of the Microbiology Lab's new equipment.
- Review test results and reports.
- May supervise the Microbiology Lab's technical personnel.
- Create budgets for the Microbiology Lab.
- Coordinate the purchase of the equipment needed for the laboratory's operation.
- Participate as internal auditor in ISO 13485 and GRS/GMPS.
- Establish and maintain the product testing program for bioburden and LAL.
**Requirements**
The ideal candidate will have a Licenciature degree in Biotechnology, Microbiology, Biology, or a related field, with a strong background in Microbiology and Sterilization. English language proficiency is required, with a desired level of B2 (80-89%). The candidate should also have at least 2 years of experience in a similar position.
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