IT Engineer – CSV
AKKA Technologies
Neuchâtel
vor 13 Std.

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.

    Profile

  • 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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