Sterility Assurance Expert

CAI; Milano; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

Une entreprise leader dans le domaine de l'assurance de stérilité recherche un expert basé à Milan. Ce poste implique des responsabilités clés telles que l'évaluation des risques dans les processus aseptiques, la qualification des équipements et la gestion de projets croisés. Les candidats doivent posséder un diplôme en microbiologie ou un domaine connexe et être prêts à voyager à travers l'Italie et parfois en Europe.

Competenze

• Compréhension des bonnes pratiques de documentation.
• Capacité à gérer plusieurs projets simultanément.
• Compétences en communication en anglais ou langue maternelle.

Mansioni

• Réaliser des évaluations et qualifications des équipements de stérilisation.
• Participer à la rédaction de protocoles, rapports et spécifications.
• Participer à des projets transversaux et à des réunions avec les clients.

Conoscenze

Aseptic technique

Contamination control strategy

Attention to detail

Organizational skills

Independence

Formazione

Degree in microbiology, biology, biotechnology or science-related field

Descrizione del lavoro

Leads Sterility Assurance assessment in regulated manufacturing industry.

Experience in Environmental qualification and Contamination control Strategy.

Experience in aseptic process simulation risk assessment, validation strategy and oversight.

Experience in Contamination control strategy of pharmaceutical sterile products.

Execution of sterilizing equipment qualification.

Experience in microbiological and biological method application and validation.

Participates in cross functional projects, including customer meetings.

Participates in the writing of protocols, reports, and specifications.

Drives deliverables to completion with structured timelines.

Requested Qualifications :

Degree in microbiology, biology, biotechnology or science-related field

Understanding of good documentation practices and general quality laboratory function.

Ability to work independently and manage multiple projects simultaneously.

Strong attention to details, organizational skills and drive to be successful.

Experience with aseptic technique and biological safety cabinets.

Proficient in spoken and written English and / or a native language

Suitable candidates must be available for travel throughout Italy and some European travel may be required.

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Sterility Assurance Expert • milano, Italia