IT Engineer – CSV

CDI

Neuchâtel

12/03/2020

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Référence

2020-13527

Catégorie

Operations — Consulting

Secteur Industriel

Life sciences

Niveau d'expérience

3 à 5 ans

Localisation

Suisse, Neuchâtel

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Description

The role

  • Information Technology Requirements, GmP Regulation, must be explained
    and obtained from the vendor of system. When necessary, the Engineer, may
    have to customize the system, or adapt the process, to comply the GmPs.
  • Guarantee Data Integrity of the system into its environment and process.
  • Facilitate meetings with business colleagues on IT topics
  • Assist the translation of compliance requirements into test conditions and expected results for application functionality, and acceptance testing (IQ,PQ,FAT)
  • Understand business objectives, processes, and strategies.
  • Drive development and execution of change management and training throughout the organization during the implementation and ongoing use of system applications
  • Ability to work strategically and independently with internal and external groups on multiple simultaneous projects
  • Understand and ensure the use of existing standards for design and governance.
  • Implement specific standalone and interconnected computerized system
    supporting activities like Production (e.g.: Laetus Track & Trace, Blending,
    Encapsulation, Tablet Press, Blistering, Bottling, Cartoning , Room Monitoring System and other various equipment used for the manufacturing, packaging and Quality Control of drug products.

Profil

  • Pharmaceutical, Biotechnology, Life Science industry experience is a must.
  • 3-5 years’ experience as an IT Engineer running project from requirements to delivery of final product and documentation included.
  • Familiar with Change Management tools and regulated document authoring.
  • Web-based requirements, architecture, Agile/SCRUM methodology.
  • Real Time Data Management and Interfaces (e.g.: Kepware, OSI PI) a strong plus
  • Serialization technologies (Laetus) a strong plus
  • Six Sigma, Lean or Business Process Change Techniques a plus
  • Languages: French + English
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