CSV Consultant

2 settimane fa

Milano, Lombardia, Italia fortil A tempo pieno

Fortil is an international engineering and technology consulting group built on an independent model, bringing together over 2,500 employees. With 30 offices across 14 countries, Fortil fosters entrepreneurial freedom and the empowerment of individual potential.

We are looking for a
CSV Consultant
for a strategic project.

Location:
Monza.

Responsibilities

  • Validation of computerized systems in the Life Science sector (e.g. laboratory instrumentation control systems, automation systems and quality systems - ERP, LIMS, DMS - according to the GxP reference regulations and GAMP Guidelines;
  • Support in the management of remediation or requalification projects for the adaptation of computerized systems to the FDA 21 CFR part 11/EU Annex 11 regulations and to the Data Integrity regulations and guidelines;
  • Periodic review of computerized systems and user audit trails;
  • Drafting of validation documents: Validation Plans, URS, Traceability Matrices;
  • Drafting and execution in the field of test protocols: IQ/OQ/PQ;
  • Drafting of Risk Assessments;
  • Drafting of computerized system administration procedures;

About You

  • Bachelor's or Master's degree in technical-engineering or similar subjects (Chemical Engineering, Chemistry, Industrial Chemistry, Mechanical Engineering, CTF, Pharmacy, Biology);
  • 3+ years of experience on CSV projects in the Life Science field;
  • Skilled in mapping data flows and performing gap analyses to identify compliance and process improvement opportunities
  • Good knowledge of the reference regulations and guidelines. In particular, knowledge of GMP, CFR 21 Part 11 Regulations, EU/GMP Annex 11, ISPE GAMP5; guidelines, data integrity regulations and guidelines (e.g. MHRA, WHO, EMA, FDA) and ICH guidelines, in particular ICHQ9, is required;
  • Good knowledge of the English language, both written and spoken;
  • Excellent knowledge of the Office package;

Why join us?
At Fortil, we implement concrete initiatives to support your development and ensure an inspiring work environment:

  • Personalized support to help you grow your skills
  • An ecosystem that encourages you to step outside your comfort zone
  • The opportunity to become a shareholder
  • Involvement in community and non-profit projects
  • A dedicated policy to support parenthood

Fortil is committed to equal opportunity. All our positions are open to people with disabilities, regardless of gender, origin, or sexual orientation.

  • CSV Consultant

    4 giorni fa

    Milano, Lombardia, Italia fortil A tempo pieno

    Fortil is an international engineering and technology consulting group built on an independent model, bringing together over 2,500 employees. With 30 offices across 14 countries, Fortil fosters entrepreneurial freedom and the empowerment of individual potential.We are looking for aCSV Consultantfor a strategic...

  • CSV Consultant

    4 giorni fa

    Milano, Lombardia, Italia fortil A tempo pieno

    ortil is an international engineering and technology consulting group built on an independent model, bringing together over 2,500 employees. With 30 offices across 14 countries, Fortil fosters entrepreneurial freedom and the empowerment of individual potential.We are looking for aCSV Consultantfor a strategic...

  • Junior Pharma Validation Consultant

    2 settimane fa

    Milano, Lombardia, Italia PQE Group A tempo pieno

    Sei pronto per entrare a far parte di una società di consulenzaleader mondialenell'industria farmaceutica e dei Medical Device?PQE Groupopera con successo in questo settore dal 1998, garantendo una presenza internazionale grazie a45 filialie2000 dipendentiin Europa, Asia e Americhe.Lavorare in una realtà di consulenza come PQE Group ti offrirà:La...

  • Senior Csv Consultant

    2 settimane fa

    Milano, Italia Buscojobs IT C2 A tempo pieno

    COMPANYThey are a Milan-based company that provides engineering, validation, and quality assurance services for new and existing systems, equipment, and facilities.They also offer auditing, testing, commissioning, and automated system validation in compliance with international standards.CANDIDATE PROFILEWe are seeking a hands-on Senior CSV Consultant with...

  • CSV Consultant

    1 settimana fa

    Milano, Italia Altro A tempo pieno

    CSV Consultant (Monza) Role at fortil Location: Monza. Fortil is an international engineering and technology consulting group built on an independent model, bringing together over 2,500 employees. With 30 offices across 14 countries, Fortil fosters entrepreneurial freedom and the empowerment of individual potential. We are looking for a CSV...

  • Csv Consultant

    1 giorno fa

    Milano, Italia Fortil A tempo pieno

    CSV Consultant (Lombardia)Fortil is an international engineering and technology consulting group built on an independent model, bringing together over 2,500 employees.With 30 offices across 14 countries, Fortil fosters entrepreneurial freedom and the empowerment of individual potential.Location:Lombardia.ResponsibilitiesValidation of computerized systems in...

  • Csv Consultant

    1 settimana fa

    Milano, Italia Fortil A tempo pieno

    CSV Consultant (Monza)Role at fortilLocation: Monza.Fortil is an international engineering and technology consulting group built on an independent model, bringing together over 2,500 employees.With 30 offices across 14 countries, Fortil fosters entrepreneurial freedom and the empowerment of individual potential.We are looking for aCSV Consultantfor a...

  • Csv Consultant

    4 giorni fa

    Milano, Italia Fortil A tempo pieno

    ortil is an international engineering and technology consulting group built on an independent model, bringing together over 2,500 employees.With 30 offices across 14 countries, Fortil fosters entrepreneurial freedom and the empowerment of individual potential.We are looking for a CSV Consultant for a strategic project.Location: Lombardia.Responsibilities...

  • Csv Consultant

    1 settimana fa

    Milano, Italia Altro A tempo pieno

    CSV Consultant (Monza) Role at fortil Location: Monza.Fortil is an international engineering and technology consulting group built on an independent model, bringing together over 2,500 employees.With 30 offices across 14 countries, Fortil fosters entrepreneurial freedom and the empowerment of individual potential.We are looking for aCSV Consultantfor a...

  • Csv Validation Specialist – Life Sciences

    1 settimana fa

    Milano, Italia Fortil A tempo pieno

    A global consulting firm is seeking a CSV Consultant based in Monza.This role involves validating computerized systems in the Life Science sector and supporting compliance with regulatory standards.Candidates should hold a relevant degree and have over 3 years of experience in CSV projects.The position offers opportunities for professional growth,...

  • Csv Consultant

    4 giorni fa

    Milano, Italia Fortil A tempo pieno

    ortil is an international engineering and technology consulting group built on an independent model, bringing together over 2,500 employees. With 30 offices across 14 countries, Fortil fosters entrepreneurial freedom and the empowerment of individual potential.We are looking for aCSV Consultantfor a strategic...

  • Csv Consultant

    13 ore fa

    Milano, Italia Fortil A tempo pieno

    Fortil is an international engineering and technology consulting group built on an independent model, bringing together over 2,500 employees. With 30 offices across 14 countries, Fortil fosters entrepreneurial freedom and the empowerment of individual potential.We are looking for aCSV Consultantfor a strategic...

  • Computer System Validation

    1 settimana fa

    Milano, Italia Buscojobs IT C2 A tempo pieno

    L'AZIENDAIl nostro cliente, con sede a Milano, è un player con alto posizionamento nell'ingegneria, convalida e quality assurance per sistemi, apparecchiature e impianti, sia nuovi che esistenti. Fornisce inoltre servizi di auditing, testing, commissioning e convalida di sistemi automatizzati, conformi ai più elevati standard internazionali.IL RUOLOStiamo...