Equipment Validation Lead

4 settimane fa

Roma, Lazio, Italia Thermo Fisher Scientific A tempo pieno

When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe.
Your work will have real-world impact, and you'll be supported in achieving your career goals.
Location/Division Specific Information
Ferentino, Italy
How will you make an impact?
Ensure the effective and efficient execution of utilities and equipment qualification activities through the planning and control of the progress of daily activities, in order to meet the project target for new product introduction or modification on plant and equipment already in use.
The Equipment validation Lead in the project team works with Technology Transfer team and Engineering team to define qualification strategy, to schedule qualification activities and to ensure the correct execution of qualification protocol.
What will you do?
- Assicurare, in accordo con il manager, l'analisi e la valutazione della documentazione técnica relativa agli impianti che devono essere sottoposti a qualifica o riqualifica al fine di acquisire informazioni necessarie alla definizione dei protocolli e alla esecuzione delle attività.
- Redigere con il supporto di società di consulenza Protocolli di qualifica/riqualifica (Protocolli di IQ-OQ-PQ), attraverso la ricerca e l'acquisizione dei dati e delle informazioni necessarie per definirne i contenuti nonché coinvolgendo le funzioni aziendali relativamente alla definizione delle attività che dovranno svolgere.
- Assicurare la corretta qualifica/riqualifica degli impianti e macchinari, attraverso l'esecuzione delle attività operative previste dai Protocolli (Protocolli di IQ-OQ-PQ) e il coordinamento delle attività svolte dalle altre funzioni aziendali, nel rispetto dei protocolli e delle procedure aziendali.
- Effettuare una corretta analisi delle attività di qualifica, attraverso la raccolta dei dati e dei risultati generati, nel rispetto dei protocolli e delle procedure aziendali.
- Redigere Rapporti di qualifica (Report IQ-OQ-PQ), sulla base dell'analisi dei dati emersi dalle attività di convalida, nel rispetto dei protocolli e delle procedure aziendali.
How will you get here?
Education
Degree in Engineering, CTF or other similar fields
Experience
- Experience in pharmaceutical industries
- At least 3 years' experience in validation of equipment and utilities used for sterile manufacturing
Knowledge, Skills, Abilities
- Knowledge of the main regulation and guide lines concerning Qualification activities
- Knowledge of GMP and national/international regulations
- Good problem-solving abilities
- Proficiency in Microsoft Office suite
- Be prepared to work with conflicting priorities, under time constraints and in a dynamic team environment
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell.
Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

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