Our Vacancy

Ingénieur Validation de Systèmes Informatisés H/F

  • Life Sciences
  • Permanent
  • French-speaking Switzerland
  • English (Technical)
  • 12/11/2021
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About Assystem

For 50 years, we've been driven by the firm belief that engineers are the architects of tomorrow's world, leading the way with their daring, their expertise and their ability to push boundaries.
Together with our customers, our 7,000 employees innovate on a daily basis and contribute to accelerating energy transition throughout the world. They support the world's greatest engineering projects in the fields of energy, healthcare, life sciences and transport.
A fast-growing international Group, we are present in 15 countries (in Europe, the Middle East, Asia and Africa).

Well known for our expertise in CQV (Commissioning Qualification Validation) and specialists in projects with strict technical and regulatory constraints, we partner pharmaceutical laboratories and high-tech industrial players to manage their capital expenditure and meet the challenges they face in terms of increasing safety and reducing costs and market lead times.
We innovate for our clients and provide them with disruptive technologies in the areas of data integrity, cybersecurity and predictive maintenance.

Assystem CARE combines 30 years of expertise in health and life sciences: the strength of engineering, the power of digital and experience in managing complex projects allow us to operate in highly regulated environments. We are a reference partner, agile and reliable in ensuring the success of projects in the health and life sciences industries.

Job Description

Dans le cadre de notre participation au pilotage de projets sur des sites industriels pharmaceutiques, Vous intervenez sur la qualification/validation des systèmes informatisés selon les référentiels BPF et 21CFR part 11.

Interlocuteur/Interlocutrice des partenaires informatiques, votre mission comprend :

  • Réalisation d’un inventaire des systèmes et description des systèmes (flux de données, matrice des droits, gestion des audits-trails) ;
  • L'élaboration de la stratégie de validation ;
  • La constitution du plan directeur et du plan de validation ;
  • L'analyse de risques ;
  • La qualification de conception (QC) ;
  • La rédaction de protocoles de Qualification d'installation (QI) / Qualification opérationnelle (QO) / Qualification de performance (QP) ;
  • La rédaction de fiches de tests associées;
  • L'assistance à l'exécution des tests et rapports de qualifications et validation ; 
  • L'interface avec les fournisseurs et/ou les clients.
  • Le respect de la conformité des réalisations, des procédures internes, des normes et réglementation.

Profile

De formation Ingénieur ou Master en Automatisme, Informatique industrielle ou équivalent, vous avez acquis une expérience significative d'au moins 2 ans dans le secteur de l'industrie pharmaceutique en validation des automates et systèmes d'informations.

Connaissances des exigences règlementaires et normes suivantes requises :

  • 21 CFR part 11,
  • GAMP,
  • GMP, BPF
  • Réglementation analyse de risques,
  • Automates et langages associés (Schneider, Siemens, Rockwell…).
     

 Vous disposez d'un bon niveau d'anglais et de fortes capacités d'analyses, de synthèse et d'adaptation.

At Assystem, everyone holds the reins for their own careers. Our role is to offer you the opportunities and resources you need to reach your full potential.

So why not join us and help shape the engineering landscape of the future?

 

We are committed to providing equal opportunities for every candidate and we celebrate all forms of diversity. At Assystem, only your skills matter!

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