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Commissioning & Qualification Engineer

Lucerne, Switzerland   •  Contract/Temporary, Full time


QLS are recruiting for a Commissioning and Qualification Engineer to join a project with an Global Biopharmaceutical Company based in Lucerne on a contract basis for over 2 years.

Main Responsibilities

  • Equipment Qualification and Computer System Validation (CSV) of various process and laboratory equipment, and utilities. Generation and execution of documents needed for computer validation and equipment qualification (i.e. generation and execution of DQ, IQ, OQ, PQ).
  • Upon termination of tasks of a project, the candidate will issue qualification summary reports. Periodical reviews of current qualification documentation to confirm the qualification state of the equipment.
  • Participation in efficiency and streamlining meetings to contribute to qualification projects. Based on development within the role, the candidate will be organizing these optimization meetings for his own projects.
  • Execution of test scripts. One day in the job: Focus on the projects that have the highest priority. Initiate new project in the electronic testing software (ETS).
  • Set-up of meetings with the stakeholders to gather required information that are needed to prepare the qualification documents. After specification of URS and Risk analysis, develop test cases for the qualification of the equipment.
  • Conduction of a dry run before starting review and approval workflow of the test cases and before execution of the testings.
  • Definition of calibration and maintenance tasks together with business and add the defined PM into the CCMS system.
  • Preparation of a close-out report of the qualification project to get the newly qualified equipment into GMP process.

Candidate?s Requirements:

  • Master or bachelor in a technical discipline (e.g. Biotechnology, Chemistry).
  • Strong affinity to technologies.
  • Great interest in understanding physical, chemical processes and computer/software technology.
  • Precise way of working. Quick grasp. Good communication skills (written and spoken).
  • Enjoy teamwork. Flexible, open-minded and resilient personality.
  • Languages: English and German fluent in written and spoken (min. B2 level)

The position offers great development opportunities for a junior engineer in a dynamic, technically demanding and highly regulated environment.

Apply:
Please could you send any correspondence in English. Please quote job reference 54217 in all correspondence.


You must have the right to work in Switzerland.

  • Agency: CK Group
  • Reference: 54217
  • Posted: 5th August 2022
  • Expires: 2nd September 2022

CK Group

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