Microbiologist III 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

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Microbiology, Test Methods, Quality System, Regulatory Submissions, Bioburden Testing, Endotoxin Testing, SOPs, Technical Guidance, Troubleshooting, Cross-Functional Teams, Internal Audits, External Audits, Data Presentation, Cleanroom Standards, Sampling Plans, Compliance

Industry

Medical Equipment Manufacturing

Description

Strong knowledge of microbiology test methods, standards and regulations governing the quality system and microbiological topics. Review and assess from a microbiology context all changes that impact product or the cleanroom environment. Support new product development by participating as the microbiology functional team member and represent the Microbiology department on cross-functional project teams as required. Support Regulatory submissions by conducting review to ensure appropriate microbiology information is present in the submission. Review test reports from internal, external testing for compliance to BSC and external compliance requirements. Ensures that products are validated for bioburden and endotoxin testing and support the establishment of routine sampling plans. Support Internal/External Audits and ensures all non-conformances are adhered to in a timely manner. Provide technical guidance/troubleshooting in the event of Microbiology related issues. Act as Quality Engineer for Facilities related matters. Revise SOPs and support maintenance of product and environmental documentation. Support product bioburden alert limits and cleanroom air and surface alert and action limits periodical revision. Organizes and presents data/ information to influence decision making, primarily to internal audiences Degree in Microbiology, Biotecnology or related field. At least 3 years of experience in similar position. English Level desired: 80-89%. Requisition ID: 616435 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

The Microbiologist III will review and assess changes impacting product or cleanroom environments, support new product development, and ensure compliance with microbiology standards. Additionally, the role involves conducting reviews for regulatory submissions and providing technical guidance on microbiology-related issues.