C&Q Engineer II

Commissioning & Qualification Engineer, Werthenstein, Switzerland, Fulltime.

Duration: 1 year with possibility for an extension.

Start Date: Beginning 2025.

The Validation Unit (VU) is a core team at the Werthenstein location (Lucerne). The unit interacts daily with other departments in different projects, being the primary task the qualification and validation of site equipment and utilities. These are mainly laboratory and manufacturing equipment, water, compressed gases and air systems. The candidate would join a dynamic and multinational team of more than 20 people. Communication within the location is held both in 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 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.
• Participate 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 their own projects.

Execution of test scripts Qualifications:

• Requires master or bachelor 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 pharmaceutical industry and good understanding of GMP guidelines.
• 1-3 years of previous computer validation experience a plus.
• Languages: English and German fluent in written and spoken (min. B2 level).
• Personality: Proactive, open-minded, independent working attitude.
• Flexible mentality and understanding of work in interdisciplinary teams.
• Good affinity for IT systems.
• Preferred candidate would require a minimal work direction and is highly skilled and knowledgeable to the position.

Apply:

If you are interested, could you please send me an updated CV in English to . Please quote job reference in all correspondence.