Commissioning and Qualification Engineer
The Validation Unit (VU) is a core team at the Werthenstein location (Lucerne). The unit interacts daily with other departments in different projects, primarily focusing on the qualification and validation of site equipment and utilities, including laboratory and manufacturing equipment, water, compressed gases, and air systems. The candidate will join a dynamic and multinational team of more than 20 people, with communication in both German and English.
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 project tasks, issue qualification summary reports and conduct periodic reviews of current qualification documentation to confirm the qualification state of the equipment.
* Participate in efficiency and streamlining meetings to contribute to qualification projects.
* Organize optimization meetings for their own projects based on development within the role.
* Execution of test scripts.
Qualifications :
* Master’s or Bachelor’s degree in a technical discipline (e.g., Biotechnology, Chemistry).
* Qualification / Validation experience is strongly preferred (i.e., generation and execution of DQ, IQ, OQ, PQ).
* Good understanding of regulatory and qualification requirements.
* Previous experience in a highly regulated environment, primarily in the pharmaceutical industry, and good understanding of GMP guidelines.
* 1-3 years of previous computer validation experience is a plus.
* Languages : English and good knowledge of German in written and spoken (B1-B2 level).
* Personality : Proactive, open-minded, with an independent working attitude.
* Flexible mentality and understanding of work in interdisciplinary teams.
* Good affinity for IT systems.
* Preferred candidate requires minimal work direction and is highly skilled and knowledgeable in the position.
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