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CSV Engineer Emploi Plein temps

il y a 4 mois Engineering Allschwil
Détails de l'annonce

Founded in 1968, SKAN is a pioneer in cleanroom equipment and the development of isolators for the pharmaceutical industry. Innovative products, tailor-made solutions and an effective service organisation have made SKAN a market leader and a key partner to industry and research laboratories.

At SKAN, healthy growth is important to us. We are always looking for talented individuals to fill a wide range of roles. Apply now!

Responsibilities

  • Co-design of the test procedure according to 21 CFR Part 11 and GAMP5
  • Co-design of the internal processes as well as those of the related departments
  • Coordination of quality-relevant relationships with the internal automation departments (deviations, CAPA, changes)
  • Creation of specifications for the simulation/validation components (e.g. for the WinMOD macros, certificate FDA 21 CFR Part 11 Compliance)
  • Creation and maintenance of instructions in the area of validation of the automation software
  • Carrying out software module tests and reviews
  • Administration and maintenance of the validation documents (e.g. SIT FT)
  • Support in the creation of the WinMOD applications and the test stations or similar virtualised system with behaviour simulation


Hardskills

  • Engineer FH, HF with specialisation in electrical engineering or automation
  • Several years of professional experience in plant engineering, preferably with a pharmaceutical background
  • Experience in control engineering
  • PLC programming knowledge, preferably of Siemens (Step 7/TIA) and/or Allen Bradley controllers
  • Confident handling of MS-Office and EDP systems
  • German and good technical English skills


Softskills

  • Precise and careful way of working
  • Coordination skills, ability to work under pressure and in a team
  • High level of personal responsibility
  • Competent and professional appearance
  • Willingness to travel worldwide approx. 10% of the time


We offer you

  • An open and collegial corporate culture
  • Freedom for ideas
  • Participation in sports and leisure activities
  • Promotion through further training, especially at our SKAN Academy
  • Intensive and job-oriented introduction
  • Short decision-making paths and flat hierarchies
  • Open communication policy
  • 5 weeks holidays and the possibility of further holidays


For questions please contact Désirée Gallicchio