Specialist, Equipment Validation

3 giorni fa


Ferentino, Italia Thermo Fisher Scientific A tempo pieno

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Office

**Location/Division Specific Information**:
Ferentino, Italy

**Discover Impactful Work**:
Ensure the execution of the qualification activities of the Site Equipment reported in the written protocol. Assure the tests are in line with the main guidelines and GMP.

**A day in the Life**:

- Perform the analysis and evaluation of technical documentation for system to be qualified in order to acquire information necessary for the issue of protocols and the execution of activities.
- Issue of qualification protocols (IQ-OQ-PQ Protocols), through research and acquisition of data and information necessary to define their contents.
- Lead the external consultants in order to assure the correct qualification of the system/equipment (IQ-OQ-PQ Protocols)
- Carry out the analysis of the qualification activities and issue the qualification reports (IQ-OQ-PQ report), in compliance with current regulations (current EU GMP, US GMP) and company quality standards.
- Support the Quality Department in preparing Customer Audits and Regulatory Inspections, providing necessary information and documentation.
- Collaborate with other Site Departments in order to achieve the goal of the company’s projects.
- Participate in calls/meetings with customers/clients to support the discussion on topics related to equipment qualification.
- Collaborate with the Team Leader to close on time all assigned project.

**Keys to Success**:
**Education**:

- Technical / Scientific Degree (Mechanical Engineering, Chemical Engineering, CTF, Biomedical Engineering, Pharmacy, Industrial Chemistry)

**Experience**:

- Experience in pharmaceutical industries
- At least 2 years’ experience in Equipment Qualification Department

**Knowledge, Skills, Abilities**:

- Knowledge of the main pharmaceutical machines/systems
- Fluent in English
- Good Team-worker
- Good problem-solving abilities
- Proficiency in Microsoft Office suite and electronic systems such as Documentum and Trackwise
- Be prepared to work with conflicting priorities, under time constraints and in a dynamic team environment

**Benefits**:
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation



  • Ferentino, 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. **How will you make an impact?** You will join the site...


  • Ferentino, 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...


  • Ferentino, Italia Thermo Fisher Scientific A tempo pieno

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeLocation/Division Specific InformationFerentino, ItalyDiscover Impactful Work:Ensure the execution of the qualification activities of the Site Equipment reported in the written protocol. Assure the tests are in line with the main guidelines and GMP.A day in the Life:Perform the analysis and...


  • Ferentino, Italia Thermo Fisher Scientific A tempo pieno

    **Analisi della documentazione técnica** 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. **Definizione...


  • Ferentino, Italia Thermo Fisher Scientific A tempo pieno

    **Job tasks**: **Analysis of the technical documentation**: Ensure, in agreement with the manager, the analysis and evaluation of the documentation relating to the plants that must undergo qualification or requalification in order to acquire all the details necessary to issue the protocols and to implement validation activities. **Protocol...


  • Ferentino, Italia Biomedica Foscama - CDMO Services A tempo pieno

    Presso il sito della Biomedica Foscama I.C.F. di Ferentino, siamo alla ricerca di un Addetto QA Validation con le seguenti caratteristiche:COMPITI E RESPONSABILITA'Collaborare con le risorse del settore qualifiche.Stesura dei documenti di Qualifica/Taratura di macchine, impianti, equipment sia esistenti che di nuova installazione.Esecuzione delle attività...


  • Ferentino, Italia Thermo Fisher Scientific A tempo pieno

    **Analisi della documentazione técnica** 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. **Definizione...


  • Ferentino, Italia Biomedica Foscama - CDMO Services A tempo pieno

    Presso il sito della Biomedica Foscama I.C.F. di Ferentino, siamo alla ricerca di un Addetto QA Validation con le seguenti caratteristiche:COMPITI E RESPONSABILITA'Collaborare con le risorse del settore qualifiche.Stesura dei documenti di Qualifica/Taratura di macchine, impianti, equipment sia esistenti che di nuova installazione.Esecuzione delle...


  • Ferentino, Italia Biomedica Foscama - CDMO Services A tempo pieno

    Presso il sito della Biomedica Foscama I.C.F.di Ferentino, siamo alla ricerca di un Addetto QA Validation con le seguenti caratteristiche: COMPITI E RESPONSABILITA' Collaborare con le risorse del settore qualifiche.Stesura dei documenti di Qualifica/Taratura di macchine, impianti, equipment sia esistenti che di nuova installazione.Esecuzione delle attività...


  • Ferentino, Italia Thermo Fisher Scientific A tempo pieno

    Draft of Validation Protocols (cleaning, Process, Media Fill), by acquiring information from other departments to define their contents (e.g. process parameters, sampling plan) as well as collaborating with company functions to define actions to be carried out, as per company procedures. Handle periodic cleaning validation and aseptic fillings (Media Fill)....

  • Csv Specialist

    1 settimana fa


    Ferentino, Italia Thermo Fisher Scientific A tempo pieno

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our...


  • Ferentino, Italia Thermo Fisher Scientific A tempo pieno

    **How will you make an impact?** Ensure the Quality of the Technical Area Departments, dealing in particular with the management of Customer Audits and Regulatory Inspections, Deviations, CAPAs, Changes, SOPs relating to Process Maintenance and Utilities, Calibrations and Equipment Qualification. **What will you do?** - Support the Quality Department in...


  • Ferentino, Italia Thermo Fisher Scientific A tempo pieno

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office Summarized Purpose: Assist with all data management project management-related activities, including all aspects necessary for a successful setup, conduct and closeout of assigned studies. Supports closeout/lock of the study databases by working with internal (IS and PM) and...

  • Technology Capital

    2 giorni fa


    Ferentino, Italia Thermo Fisher Scientific A tempo pieno

    **SCOPO DELLA POSIZIONE/RESPONSABILIT**À**: Assicurare gli aspetti di Qualità dell’area Tecnica, occupandosi in particolare: della gestione sia delle Audit da parte dei clienti che delle Ispezioni Regolatorie, delle Deviazioni, dei CAPA, dei Change, delle SOP, afferenti all’area di competenza costituita da Servizi Tecnici (Manutenzione di Processo e...


  • Ferentino, Italia Thermo Fisher Scientific A tempo pieno

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office Position Summary: Join Thermo Fisher Scientific Inc. as a Technical training and support engineer and have the unique opportunity to build, grow, and share your...


  • Ferentino, Italia Thermo Fisher Scientific A tempo pieno

    **Technology Transfer Project Manager** When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $24 billion and the largest investment in...

  • Qc Pds Ad

    6 giorni fa


    Ferentino, Italia Thermo Fisher Scientific A tempo pieno

    When you’re part of Thermo Fisher Scientific, you’ll do daring work, and be part of a team that values performance, quality and innovation. **Position Summary**: This position is responsible for performing quality control testing of raw material, API / DS, semi-finished and finished products (Release and Stability) in accordance with the shipping...

  • Brr Qof

    7 giorni fa


    Ferentino, Italia Thermo Fisher Scientific A tempo pieno

    **Work Schedule** Flex Shifts 40 hrs/wk **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves,...


  • Ferentino, 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,...


  • Ferentino, 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,...