Senior Biocompatibility Specialist

Chi siamo

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 www.enovis.com.

Who We Are

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 www.enovis.com.

Di cosa ti occuperai | What You'll Do

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 www.enovis.com.

Per i nostri uffici basati a San Daniele del Friuli (UD - Italy), siamo alla ricerca di un Senior Biocompatibility Specialist esperto e attento ai dettagli per unirsi al Quality Assurance Department all’interno della International Surgical Division. Il candidato selezionato avrà la responsabilità di coordinare e svolgere le attività di testing microbiologico, supportare i processi di produzione asettica e garantire la conformità a standard regolatori. Questo ruolo è fondamentale per il rilascio del prodotto, il supporto alla validazione e la garanzia di qualità complessiva.

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, cleanrooms, 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 proficiency in written and spoken English (at least B2 level according to the CEFR)
• Excellent analytical, organizational, and communication skills.

Preferred Skills

• Familiarity with FDA, EMA, and other regulatory guidelines.
• Experience in writing and reviewing SOPs and validation protocols.
• Ability to work independently and collaboratively in cross-functional teams.

EOE AA M/F/VET/Disability Statement

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.

Dichiarazione di pari opportunità

Enovis si impegna a garantire pari opportunità di lavoro a tutti. Le decisioni relative all'assunzione si basano esclusivamente sul merito, sulle qualifiche e sulle esigenze aziendali. Applichiamo una politica di parità di trattamento per tutti i dipendenti e i candidati, senza discriminazioni basate su razza, colore della pelle, religione, nazionalità, sesso, orientamento sessuale, identità di genere, età, status di veterano, disabilità o qualsiasi altra caratteristica non correlata alle qualifiche o alle prestazioni lavorative di una persona. Questo impegno si estende a tutti gli aspetti dell'occupazione, tra cui reclutamento, assunzione, assegnazione dei compiti, retribuzione, formazione, promozione, retrocessione, trasferimenti, licenziamenti, provvedimenti disciplinari e cessazione del rapporto di lavoro, nonché a tutti gli altri termini e condizioni di impiego.

EOE AA M/F/VET/Disability Statement (English)

At Enovis, we are committed to providing equal employment opportunities to all individuals. Employment decisions are based solely on merit, qualifications, and the needs of the business. We uphold a policy of equal treatment for all employees and applicants, without discrimination based on race, color, religion, national origin, sex, sexual orientation, gender identity, age, veteran status, disability, or any other characteristics unrelated to a person’s qualifications or job performance. This commitment extends to all aspects of employment, including recruitment, hiring, job assignments, compensation, training, promotion, demotion, transfers, layoffs, discipline, and separation, as well as all other terms and conditions of employment.