Boston Scientific Sr Microbiologist 

Costa Rica 

927811758

About the Role:

As a key contributor, this position will support the successful launch of transfer and new products, ensuring microbiological and cleanroom readiness. This position also plays a vital role in preparing the site for inspections by regulatory authorities and external audits.

Your Responsibilities Include:

· Serve senior matter expert on microbiology related topics, assuring the controlled environment areas and product meets documented requirements and that processes are controlled.

· Supports the Controlled Environment Rooms and critical systems (OFA & HPW) qualification processes.

· Establish and maintain the monitoring program of controlled environments.

· Maintain the finished goods microbiological testing program.

· Maintain the site´s water systems monitoring.

· Make sure all Microbiology Lab procedures meet corporate requirements, as well as international regulations such as QSR/GMPs and ISO 13485.

· Lead tasks related to Microbiology Investigation Systems, such as generation of metrics and monitoring the corrective and preventive actions feeder system.

· Oversee the validation of the Microbiology Lab´s new equipment.

· Review test results and reports.

· Supervise the Microbiology Lab´s technical and professional 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.

· Act as Quality Engineer for Facilities related matters.

What We’re Looking For:

• Licenciature degree in Microbiology, Biotechnology, Biology,Chemical , or Related Field

• English Level required: B2:(80-89%).

• At least 5 years of experience in similar position

• Desired knowledge: Sterilization of medical devices, Microbiology Control for Cleanrooms, Microbiology testing validation and Cleanrooms Qualification.

• Desirable experience in ISO 13485, QSR/GMPs, Internal auditor experience is a plus.