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MS&T Intern

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Thermo Fisher Scientific

1mo ago

  • Internship
    Full-time
    Off-cycle Internship
  • Science
    Research & Development
  • Milan

AI generated summary

  • You should have a degree in scientific fields, knowledge of GMP/FDA, English and Italian fluency, teamwork skills, and familiarity with software like PMX and LIMS. Basic process validation understanding is a plus.
  • You will support validation teams by writing validation reports, technical documentation, and analyzing data, ensuring compliance with GMP, FDA, and EMA standards in sterile injectable production.

Requirements

  • Studi/Diploma/Corsi di formazione: Laurea in CTF, Farmacia, Chimica, Biotecnologie, Biologia, analoghe lauree a indirizzo scientifico o comprovata esperienza
  • Conoscenze tecniche e informatiche: Produzione e controllo della produzione di prodotti farmaceutici, Norme GMP/FDA
  • Lingue: Inglese e Italiano
  • Ottime doti relazionali, proattività, capacità di lavorare in team
  • Conoscenza dei principali sistemi informatici aziendali (PMX, LIMS, Trackwise, Minitab) e degli strumenti Microsoft Office; conoscenza di base della convalida di processo/pulizia.

Responsibilities

  • Supportare il Process & Cleaning Validation Team nell’assicurare la convalida dei processi aziendali relativi alla produzione di medicinali iniettabili sterili e alla pulizia degli equipment di produzione, attraverso la stesura di report di convalida e documenti tecnici, nel rispetto delle normative vigenti (norme GMP, FDA, EMA etc.)
  • Stesura report di convalida
  • Stesura di report di convalida relativi ai processi di fabbricazione o alle procedure di pulizia che devono essere sottoposti a convalida, al fine di acquisire informazioni necessarie alla stesura dei protocolli, l’esecuzione delle attività di convalida e la stesura dei rapporti di convalida, nel rispetto delle procedure aziendali.
  • Stesura documentazione tecnica
  • Partecipare ai team di progetto discutendo aspetti tecnici della strategia di convalida da sottomettere alle autorità regolatorie. Scrivere documentazione tecnica di Convalida, nel rispetto delle procedure aziendali.
  • Convalida
  • Supportare l’esecuzione delle attività operative dal punto di vista tecnico.
  • Rapporti di convalida
  • Revisionare i dati generati dalle attività di convalida e la loro analisi, nel rispetto dei protocolli e delle procedure aziendali.

FAQs

What is the work schedule for the MS&T Intern position?

The work schedule is standard Monday to Friday.

What are the primary responsibilities of the MS&T Intern?

The primary responsibilities include supporting the Process & Cleaning Validation Team in ensuring the validation of processes related to the production of sterile injectable drugs and cleaning of production equipment, including drafting validation reports and technical documents in compliance with regulatory standards.

What qualifications are essential for this position?

Essential qualifications include a degree in CTF, Pharmacy, Chemistry, Biotechnology, Biology, or a related scientific field, knowledge of GMP/FDA regulations, proficiency in English and Italian, and strong interpersonal skills, proactivity, and teamwork abilities.

Are knowledge of specific software systems and tools required for this internship?

While not essential, familiarity with key enterprise software systems (such as PMX, LIMS, Trackwise, Minitab) and Microsoft Office, along with basic knowledge of process/cleaning validation, is desirable.

Will I be involved in writing validation reports?

Yes, as an MS&T Intern, part of your responsibilities will include drafting validation reports related to manufacturing processes and cleaning procedures that require validation.

Is teamwork a part of the internship responsibilities?

Yes, you will participate in project teams and discuss technical aspects of validation strategies, which involves collaborating with others.

What languages are required for this position?

Proficiency in both English and Italian is required for the MS&T Intern position.

What kind of environmental conditions can I expect in this role?

The internship will be conducted in an office environment.

What type of projects will I support as an MS&T Intern?

You will support activities related to the validation of processes and cleaning in the pharmaceutical production sector, including the execution of technical documentation and analysis of validation data.

Is prior experience necessary for this internship role?

While prior experience is not mandatory, proven experience in fields related to the required studies may be beneficial.

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Thermo Fisher Scientific

The World Leader In Serving Science

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.