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

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