
Expert Microbial Scientist
1 week ago
About the Role
We are seeking a skilled Microbiologist to lead microbiological testing activities on medical devices, raw materials, and environmental samples in accordance with established protocols, regulatory requirements, and company policies.
This role is critical to ensuring accuracy, precision, and reliability of results. Your expertise will be essential in developing, executing, and overseeing microbiological test methods and procedures.
Key Responsibilities:- Develop and oversee microbiological test methods and procedures;
- Perform various microbiological analyses, including sterility testing, endotoxin testing, bioburden determination, microbial identification, and microbial enumeration;
- Design and implement protocols for environmental monitoring of manufacturing facilities and cleanrooms to ensure compliance with regulatory requirements;
- Collaborate closely with cross-functional teams to provide microbiological expertise and support during product development and manufacturing processes.
- Bachelor or Master of Science in Microbiology, Biology, or a related field; Ph.D. is a plus;
- Hands-on experience as a Microbiologist in a medical device, pharmaceutical, or similarly regulated industry;
- Strong understanding of microbiology principles, aseptic techniques, and microbial identification methods.
- Familiarity with relevant regulatory standards such as ISO 13485, FDA guidelines, and Good Manufacturing Practices (GMP);
- Excellent analytical skills and attention to detail, with the ability to accurately interpret and analyze complex data;
- Effective communication skills, both written and verbal, to convey technical information to diverse audiences.
We are committed to delivering the best structural heart products on a global scale. Our mission is to promote diversity, multiculturalism, and inclusion.
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