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Microbiologist Biocompatibility Manager, Vercelli
Client:
MicroPort CRM
Location:
Vercelli, Italy
Job Category:
Other
-
EU work permit required:
Yes
Job Reference:
662621457720803328033711
Job Views:
1
Posted:
02.05.2025
Expiry Date:
16.06.2025
Job Description:
Our mission is to create high-tech implantable devices and diagnostic solutions for cardiac diseases, accessible to many, providing valuable services to patients, physicians, hospitals, and insurers.
The Microbiology department manages microbiological and sterilization services for MicroPort CRM. We prioritize patient well-being, delivering medical devices for heart-related conditions to help people live longer and healthier lives.
Based in Saluggia, we seek a Microbiologist Biocompatibility Manager to oversee microbiological, sterilization, and biocompatibility services and lead the Microbiology & Biocompatibility COE team.
Your responsibilities include:
1. Defining, supervising, managing, and reviewing microbiological analyses of products, components, and supplies (e.g., sterility testing, bacterial endotoxins).
2. Validating sterilization processes per standards and managing routine sterilization.
3. Ensuring compliance and monitoring manufacturing areas according to standards, including hygienic rules and cleaning protocols.
4. Overseeing internal and external laboratory activities.
5. Acting as a subject matter expert in microbiology, sterilization, and biocompatibility for new product development and business continuity.
6. Managing cleanroom qualification, monitoring, trend analysis, and nonconformity management.
7. Designing and verifying device cleaning processes.
8. Developing biological evaluation plans, reviewing biocompatibility reports, and assessing chemical and toxicological data.
9. Ensuring processes comply with QMS and GMP standards.
10. Representing microbiology/sterilization topics during audits.
11. Developing and coaching the team.
12. Reviewing quality procedures, investigations, and audit responses.
13. Participating in risk management activities.
14. Leading cost improvement projects and managing budgets.
15. Contributing to product requirements and operational plans.
16. Managing cross-functional projects.
17. Interacting with internal/external stakeholders at all levels.
Your profile:
* Master's degree in Biology, Biotechnology, or related sciences.
* Knowledge of standards like ISO 11135, ISO 14644, ISO 11737, ANSI AAMI ST72, ISO 10993, etc.
* Understanding of regulations such as ISO 13485 and 21 CFR Part 820.
* People management skills.
* Advanced English proficiency.
* Proficiency in MS Office.
* Excellent communication skills.
* Experience managing large projects or processes.
* At least 8 years in biomedical or FDA-regulated environments.
What we offer:
Competitive compensation, benefits, career growth, and the chance to work in a human-scale yet international organization dedicated to life-saving products. If you have an eye for excellence and attention to detail, you can make a real difference at MicroPort CRM. Join us in helping people live longer, healthier lives.
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