Company Overview 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 pioneers in ventilators, automated pipetting, sample management, and process sensors. Hamilton Medical is a leading manufacturer of intelligent ventilators used in ICUs, emergency rescue, and MRI scans, covering various patient groups and environments.
How You Can Make a Difference We are looking for:
a highly motivated Senior Microbiologist for Quality Control in our Quality, Regulatory, and Vigilance department.
The microbiological quality control is crucial for monitoring hygiene in production areas and on medical devices to ensure end-user safety. As a Senior Microbiologist in the Biocompatibility Team, you will provide microbiological expertise by creating and implementing SOPs and work instructions to support our quality engineers at our production facilities in Domat/Ems, Graubünden. Your responsibilities include supporting new product introductions, monitoring, handling deviations, and CAPAs. You will lead investigations into cleaning and disinfection protocols with external CROs, and optimize analytical methods and facility procedures in compliance with ISO, GMP, and other standards.
Key Responsibilities Act as SME for hygiene, cleanliness, and disinfection throughout the product lifecycle.
Ensure cleanliness compliance in design control and manufacturing processes according to standards.
Generate and review technical hygiene specifications for device files and supplier agreements, ensuring accuracy and compliance.
Perform assessments, protocols, and validations related to cleaning, disinfection, and sterilization, providing validated instructions for use.
Support hygiene quality and process engineers in improving product and process hygiene, including cleanroom setup and traceability.
Review and update procedures to ensure safety and efficiency.
Contribute to monitoring processes to ensure product safety from a chemical and biological perspective.
Qualifications Required:
Master's or PhD in Microbiology or a related field.
Minimum 4 years of experience applying processes according to QMS procedures.
Experience in medical device manufacturing with a focus on cleanliness, including ISO, AAMI standards, and GMP.
Fluent in German (C1) and English (C1).
Understanding of GxP principles and microbiology fundamentals.
Preferred:
Experience in an analytical laboratory.
Experience in biocompatibility, sterile packaging, or reprocessing validations.
Travel up to 10% for supplier and affiliate support globally.
Additional Information Learn more about career opportunities at Hamilton. We offer a collaborative environment, modern working conditions, and opportunities for personal growth. Interested? Apply online using the "Apply now" button. For questions, contact us at [contact details]. Applications by post or email are not accepted.
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