Commissioning & Qualification Engineer

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 oftasks 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 technicaldiscipline (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: For more information or to apply for this position, please contact Adrien on 0041 (0) 800 106 106 or email aguimard@ckqls.ch. Please could you send any correspondence in English. Please quote reference QLS 00054217 in all correspondence.