True to the vision "We drive innovation to improve people's lives," the Hamilton companies have been providing solutions for the health sector since. We are an innovative pioneer in the fields of ventilators, automated pipetting, sample management, and the development of process sensors. Hamilton Medical is a leading manufacturer of intelligent ventilators. Whether in ICUs, during emergency rescue transport, or an MRI scan—our solutions cover a multitude of patient groups, applications, and environments.
How you can make a difference:
We are looking for...
* a highly motivated Senior Microbiologist Quality Control for our Quality, Regulatory, and Vigilance department.
The microbiological quality control is essential to ensure efficient and controlled monitoring of hygiene in production areas and on our medical devices to ensure end-user safety. As a Senior Microbiologist in the Biocompatibility Team, you will be responsible for providing microbiological expertise in creating and implementing SOPs and WIs to support our quality engineers in our production facilities in Domat/Ems, Graubünden, for new product introduction, monitoring, deviations, and CAPAs. You will support or lead task forces investigating cleaning and disinfection protocols and testing at external CROs. Additionally, you will optimize analytical methods and production facility procedures and infrastructure (cleanrooms) as needed, in accordance with ISO, ISO, and GMP standards.
You will:
* Act as SME for hygiene, cleanliness, and disinfection for new product introduction and throughout the product lifecycle.
* Be responsible for cleanliness compliance of design control and manufacturing processes according to applicable standards.
* Generate and review technical hygiene requirements specifications as part of the device technical file and supplier quality agreements, ensuring these documents are accurate and compliant with applicable standards, regulations, directives, and guidelines.
* Perform processing and reprocessing assessments, protocols, and validations to provide validated instructions for use regarding cleaning, disinfection, and sterilization to internal and external stakeholders.
* Support hygiene quality and process engineers on manufacturing sites to:
* Drive improvements to enhance product and production hygiene (cleanroom setup, semi-finished or finished goods cleaning, tool maintenance, traceability, etc.).
Review and update procedures related to production hygiene to ensure efficient procedures that ensure worker and product safety. Ensure process, tooling, and product monitoring contribute to chemically and biologically safe products.
What you bring along:
* Master's or PhD in Microbiology or a closely related field.
* At least 4 years of experience applying processes according to established QMS procedures.
* Experience in medical device manufacturing from a cleanliness perspective, particularly with standards such as ISO, AAMI TIR30, AAMI ST98, ISO series.
* Fluent in German (C1) and English (C1).
* Understanding of GxP practices and fundamentals of classical microbiology.
Additional advantages include:
* Experience in an analytical laboratory.
* Experience in biocompatibility according to ISO, sterile packaging, reprocessing, cleaning, and disinfection validations of active medical devices.
Travel up to 10% may be required to support supplier quality management and affiliated companies locally and globally.
Learn more about career opportunities at Hamilton.
If you share our values and thrive in a cooperative, down-to-earth environment, join us! We offer a motivating work environment, leisure activities, modern working conditions, and a culture of open communication. Become part of a team where your skills are valued and your innovative ideas are encouraged. Interested? Apply online using the "Apply now" button. For questions, contact us at the provided details:
Reference: JRfjm / Contact: Ilaria Cerullo
Applications by post or email cannot be considered.
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