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Ingénieur Validation Automatismes Pharmaceutiques H/F

Réf.MBL-3 - 2021/01/27

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criteria

Location :
ILE DE FRANCE
Business area :
Life Sciences
Job :
Engineering / Technical
Type of Contract :
Permanent
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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.
Every day, our 5,700 employees innovate for our clients, partnering 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 projets complexes sur un secteur à forte valeur ajoutée, vous êtes en charge de :

  • 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 ; 
  • Le respect de la conformité des réalisations, des procédures internes, des normes et réglementation.


Profile

De formation Ingénieur ou Bac + 5, vous avez une première expérience réussie de 3 à 5 ans, sur la validation des automates et systèmes d'informations au sein du secteur pharmaceutique.

Connaissances des exigences règlementaires et normes suivantes requises :

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

 

La maitrise de l'Anglais est indispensable.



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?

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