Senior Biocompatibility Specialist

Location: Town of Italy
Senior Biocompatibility Specialist page is loaded## Senior Biocompatibility Specialist locations:
San Daniele del Friuli, Friuli Venezia-Giulia, Italytime type:
Full time posted on:
Posted Todaytime left to apply:
End Date:
March 31, 2026 (30+ days left to apply) job requisition :
R0030933
** Chi siamo
**** ENOVIS
* * Enovis Corporation (NYSE: ENOV) è un'azienda in crescita nel settore delle tecnologie mediche orientata all'innovazione e dedicata allo sviluppo di soluzioni clinicamente differenziate che migliorano in modo misurabile i risultati dei pazienti e trasformano i flussi di lavoro. Grazie a una cultura del miglioramento continuo, al talento globale e all'innovazione, l'ampia gamma di prodotti, servizi e tecnologie integrate dell'azienda alimenta stili di vita attivi in ortopedia e non solo.

Per ulteriori informazioni su Enovis, visitare il sito  
** Who We Are
**** ABOUT ENOVIS
** Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit .
** Di cosa ti occuperai | What You'll Do
**** About Enovis
** Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit .For

our offices based in San Daniele del Friuli (UD - Italy), we are looking for a seasoned and detail-oriented
** Senior Biocompatability Specialist
** to join the
** Quality Assurance Department
** within the
** International Surgical Division**. The successful candidate will be responsible for coordinating and performing microbiological testing activities, supporting aseptic manufacturing processes, and ensuring compliance with regulatory standards. This role plays a key role in product release, validation support, and overall quality assurance.
*
* Key Responsibilities:

*** Prepare technical documentation related to biocompatibility, sterility, and reprocessing.
* Plan, execute, and evaluate sterilization validations and revalidations (e.g., dose setting, dose audits, dose mapping).
* Plan, conduct, and assess studies related to the biological safety of products.
* Plan, execute, and evaluate reprocessing validations (cleaning, disinfection, sterilization) for instruments and prepare reprocessing instructions for end users.
* Plan and assess monitoring activities on products, clean rooms, and water systems to demonstrate the cleanliness of final products.
* Approve sterilization validations for ODP and external suppliers.
* Conduct training sessions on hygiene, product cleanliness, sterility, reprocessing, and biocompatibility.
* Approve auxiliary and operating materials for biocompatibility assessment.
* Evaluate design and/or process changes for their impact on biocompatibility, sterility, and reprocessing.
* Review results of all tests related to product cleanliness (environment, products, water) and conduct OOS (Out of Specification) investigations.
* Review periodic re-evaluations of sterilization validations.
* Review product family classifications.
* Participate in audits as a Subject Matter Expert (SME).
*
* Qualifications:

*** Bachelor’s or Master’s degree in Microbiology, Biology, or a related scientific field.
* Minimum of 5 years of experience in a microbiology role within a pharmaceutical or biopharmaceutical manufacturing environment.
* Strong understanding of microbiological principles, aseptic techniques, and regulatory standards.
* Experience with validation, quality systems, and laboratory documentation.
* Strong…