Senior Biocompatibility Specialist – Medical Devices

Senior Biocompatibility Specialist – Medical Devices

A global, innovation-driven medical technology organization is seeking a Senior Biocompatibility Specialist to join the Quality Assurance team within its surgical devices division.

The company develops advanced medical devices solution, with a strong commitment to continuous improvement, operational excellence, and enhanced patient outcomes.

Job Description

The selected candidate will play a pivotal role in microbiological activities, aseptic process support, and regulatory compliance.

Responsibilities

• Preparing technical documentation related to biocompatibility, sterility, and reprocessing.
• Planning, executing, and evaluating sterilization validations and revalidations (e.g., dose setting, dose audits, dose mapping).
• Designing and assessing studies on the biological safety of products.
• Planning, performing, and evaluating reprocessing validations (cleaning, disinfection, sterilization) and developing reprocessing instructions for end users.
• Planning and assessing monitoring activities on products, cleanrooms, and water systems to verify final product cleanliness.
• Approving sterilization validations for internal operations and external suppliers.
• Conducting training sessions on hygiene, product cleanliness, sterility, reprocessing, and biocompatibility.
• Approving auxiliary and operating materials as part of biocompatibility assessments.
• Evaluating design and process changes for their impact on biocompatibility, sterility, and reprocessing.
• Reviewing test results related to environmental, product, and water cleanliness, and managing Out of Specification (OOS) investigations.
• Reviewing periodic re-evaluations of sterilization validations.
• Reviewing product family classifications.
• Participating in audits as a Subject Matter Expert (SME).

Requirements

• Bachelor’s or Master’s degree in Microbiology, Biology, or a related scientific discipline.
• Minimum 5 years of experience in a microbiology role within a pharmaceutical, biotechnology, or medical device manufacturing environment.
• Strong understanding of microbiological principles, aseptic techniques, and relevant regulatory standards.
• Experience with validations, quality systems, and laboratory documentation.
• Strong proficiency in written and spoken English (minimum B2 CEFR).
• Excellent analytical, organizational, and communication skills.
• Familiarity with international regulatory guidelines (e.g., FDA, EMA).
• Experience writing and reviewing SOPs and validation protocols.
• Ability to work both independently and collaboratively in cross‑functional teams.

Job location: Udine with Smart Working

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Other

Industries

• Pharmaceutical Manufacturing and Medical Equipment Manufacturing