Sr Microbiologist at Boston Scientific Corporation Malaysia

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Full Time

Start Date

Immediate

Expiry Date

02 Mar, 26

Salary

0.0

Posted On

02 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Microbiology, Biotechnology, Biology, Sterilization, Microbiology Control, Microbiology Testing, Cleanrooms Qualification, ISO 13485, QSR, GMPs, Internal Auditing, Quality Engineering, Metrics Generation, Corrective Actions, Preventive Actions, Budget Creation

Industry

Medical Equipment Manufacturing

Description

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. Degree in Microbiology, Biotechnology, Biology or related fields. English Level: 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. Requisition ID: 616433 As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! Benefits * Life-Work Integration * Community * Career Growth With determination, imagination, and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life's work. CRTA #CTGTA #QACR #CRCTA

Responsibilities

Serve as a senior subject matter expert on microbiology topics, ensuring controlled environments and products meet documented requirements. Oversee microbiological testing programs and maintain compliance with corporate and international regulations.