Chi siamo
ENOVIS™
Who We Are
ABOUT ENOVIS™
Di cosa ti occuperai | What You'll Do
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:
1. Prepare technical documentation related to biocompatibility, sterility, and reprocessing.
2. Plan, execute, and evaluate sterilization validations and revalidations (e.g., dose setting, dose audits, dose mapping).
3. Plan, conduct, and assess studies related to the biological safety of products.
4. Plan, execute, and evaluate reprocessing validations (cleaning, disinfection, sterilization) for instruments and prepare reprocessing instructions for end users.
5. Plan and assess monitoring activities on products, cleanrooms, and water systems to demonstrate the cleanliness of final products.
6. Approve sterilization validations for ODP and external suppliers.
7. Conduct training sessions on hygiene, product cleanliness, sterility, reprocessing, and biocompatibility.
8. Approve auxiliary and operating materials for biocompatibility assessment.
9. Evaluate design and/or process changes for their impact on biocompatibility, sterility, and reprocessing.
10. Review results of all tests related to product cleanliness (environment, products, water) and conduct OOS (Out of Specification) investigations.
11. Review periodic re-evaluations of sterilization validations.
12. Review product family classifications.
13. Participate in audits as a Subject Matter Expert (SME).
Qualifications:
14. Bachelor’s or Master’s degree in Microbiology, Biology, or a related scientific field.
15. Minimum of 3 years of experience in a microbiology role within a pharmaceutical or biopharmaceutical manufacturing environment.
16. Strong understanding of microbiological principles, aseptic techniques, and regulatory standards.
17. Experience with validation, quality systems, and laboratory documentation.
18. Strong proficiency in written and spoken English (at least B2 level according to the CEFR)
19. Excellent analytical, organizational, and communication skills.
Preferred Skills:
20. Familiarity with FDA, EMA, and other regulatory guidelines.
21. Experience in writing and reviewing SOPs and validation protocols.
22. Ability to work independently and collaboratively in cross-functional teams.
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