Senior Biocompatibility Specialist

Enovis; San Daniele del Friuli; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading medical device company in San Daniele del Friuli is seeking a Senior Biocompatibility Specialist to work in their Quality Assurance Department. The successful candidate will coordinate microbiological testing activities and ensure compliance with regulatory standards. Ideal candidates will have a degree in Microbiology or Biology, with at least 5 years of experience in a relevant field and strong skills in microbiological principles and aseptic techniques. This position offers an opportunity to impact product quality and safety.

Competenze

• Minimum of 5 years of experience in a microbiology role within a pharmaceutical or biopharmaceutical manufacturing environment.
• Strong proficiency in written and spoken English (at least B2 level according to the CEFR).

Mansioni

• Prepare technical documentation related to biocompatibility, sterility, and reprocessing.
• Plan and execute sterilization validations and revalidations.
• Conduct and assess studies related to biological safety of products.
• Evaluate design and/or process changes for their impact on biocompatibility.

Conoscenze

Microbiological principles

Aseptic techniques

Regulatory standards

Analytical skills

Organizational skills

Communication skills

Formazione

Bachelor’s or Master’s degree in Microbiology, Biology, or related field

Descrizione del lavoro

Senior Biocompatibility Specialist at Enovis

Located in San Daniele del Friuli (UD - Italy), the Senior Biocompatibility Specialist will work within the Quality Assurance Department of the International Surgical Division. The successful candidate will coordinate and perform microbiological testing activities, support aseptic manufacturing processes, and ensure compliance with regulatory standards. The role is critical to 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, 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.

Equal Opportunity Employment

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.

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.