Computer System Validation Engineer H/F

  • Assystem Energy & Infrastructure
  • France
  • déc. 12, 2020
Contrat CDI

Description

As a Computer System Validation Engineer you are responsible for the successful execution of the assignments that you are responsible for: • Establishing methodological and documentary validation references; • Validation of CSV throughout the whole project cycle (validation plan, risk analysis, IQ, OQ, PQ); • Undertaking Corrective Action/Preventive Action regarding CSV aspects; • Setting up tests protocols; • Guiding our clients regarding regulatory compliance and computer validation You hold at least a Master`s degree in Engineering or Pharmacy You hold at least 3 years of experience in Computer System Validation You are familiar with the processes and legal requirements for pharmaceutical industry (cGMP's, 21CFR part11, GAMP) You have a good level in Dutch and/or French and English; You are proactive, have good communication skills and you are capable of working in a multidisciplinary team towards a common goal

Description entité

Depuis 50 ans, nous sommes animés par la conviction que les ingénieurs, par leur audace, leur expertise et leur capacité à faire bouger les lignes sont les architectes du monde de demain. Tous les jours, nos 5 700 collaborateurs innovent au contact de leurs clients. Ils accompagnent les plus grands projets de l'ingénierie mondiale dans les domaines de l'énergie, de la santé, des sciences de la vie et des transports. Groupe international en forte croissance, nous sommes présents dans 14 pays (Europe, Moyen-Orient, Asie, Afrique). Acteur reconnu pour notre expertise en CQV (Commissioning Qualification Validation) et experts des projets à fortes contraintes techniques et réglementaires, nous accompagnons les laboratoires pharmaceutiques et industries de pointe dans leurs investissements et leurs enjeux liés à la sécurité et à la diminution des coûts et des délais de mise sur le marché. Pour nos clients, nous innovons et intégrons des technologies disruptives dans les domaines de l'intégrité des données, la cybersécurité et la maintenance prédictive.

Entité

Assystem Care

Mission

As a Computer System Validation Engineer you are responsible for the successful execution of the assignments that you are responsible for: • Establishing methodological and documentary validation references; • Validation of CSV throughout the whole project cycle (validation plan, risk analysis, IQ, OQ, PQ); • Undertaking Corrective Action/Preventive Action regarding CSV aspects; • Setting up tests protocols; • Guiding our clients regarding regulatory compliance and computer validation

Profil

You hold at least a Master`s degree in Engineering or Pharmacy You hold at least 3 years of experience in Computer System Validation You are familiar with the processes and legal requirements for pharmaceutical industry (cGMP's, 21CFR part11, GAMP) You have a good level in Dutch and/or French and English; You are proactive, have good communication skills and you are capable of working in a multidisciplinary team towards a common goal

Métier

Expertise Métier

Date de publication

déc. 12, 2020

Secteur

Sciences de la Vie