Computer System Validation Specialist
Alten NL
Switzerland
vor 1 Tg.

Introduction

ALTEN, the European leader in engineering and technology consulting, provides support for its clients’ development strategies in the fields of innovation, R&D and it systems.

Its 28.000 top engineers carry out studies and conception projects for the technical and information systems divisions of large corporate clients in the industrial, telecommunications and services sectors.

In a fast globalising world, ALTEN integrates with the R&D strategy of its clients to support performance and partner them in breaking into new markets.

ALTEN is active in 20 countries, covers the whole development cycle and offers a choice of service levels, from technology consulting to full-

blown project outsourcing. It is the technology partner of choice for Europe’s leading companies.

Due to the growth of the business activity, from the International Talent Acquisition Department, we are now looking for a Computer System Validation (CSV) Specialist to join our team in the Life and Science Industry in the French speaking part of Switzerland.

We are looking forward to getting to know you and your ambitions!

Responsibilities

  • Responsible of working with the automation team on fixture and automation system development as well as deployment into a manufacturing environment.
  • Responsible for Introducing and validating new equipment and / or complex new process automation projects from design through completion and in compliance with regulatory requirements.
  • Responsible for development and management of GAMP 5 documentation, as well as the 21 CFR Part 11 documentation e.g. URS, FDS, FAT, SAT, IQ / OQ / PQ etc.
  • Responsible of qualifying and validating the computer systems of the company
  • Responsible for supporting and improving existing processes through process performance monitoring, analysis, process control, and the application of engineering principles.
  • Responsible for performing troubleshooting and corrective maintenance on custom automation equipment.
  • Responsible of handling projects and tasks and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and regulatory policies, while meeting all design control and other regulatory requirements
  • Responsible of developing new documentation, operating procedures, and failure analysis guides.
  • Skills

  • Minimum : Bachelor's Degree in Engineering, Computer Science or related fields
  • Preferred : Post-graduate Degree in Electronic / Electrical / Mechatronic / Control / Software engineering
  • Understanding of design process, able to develop and execute validation test plans.
  • Strong background in GAMP 5 and 21 CFR Part 11
  • Accustomed to work in a validated environment with strong discipline with regard to change control.
  • Strong analytical and problem-solving skills.
  • Knowledge of statistical process control and data analysis by statistical methods.
  • Ability to organise, plan and execute multiple tasks to tight schedules.
  • Highly motivated self-starter with excellent communication skills.
  • Well-developed project management skills
  • English is MANDATORY, French and / or German is a plus
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