Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

As a qualification specialist, you are responsible for the qualification and validation of process engineering equipment and facilities. You make a significant contribution to the ongoing optimization of processes, systems and internal procedures and are jointly responsible for ensuring the necessary level of technical knowledge of the system staff and the engineering groups.

Key responsibilities:

• Responsible for the qualification and validation of process engineering equipment and facilities based on current regulations

• Creation and revision of qualification documents for new systems and existing systems

• Supervision of conversion, expansion and new construction projects

• Preparation and management of GMP risk analyzes according to FMEA (Failure mode and effects analysis)

• Qualifications of autoclaves and clean rooms, as well as planning and monitoring of requalifications

• Ensuring the exchange of experiences with internal and external qualification groups

• Responsible for presenting qualification documents during audits and inspections

• Internal training of employees regarding qualification and validation

Key requirements:

• Bachelor / Master / Diploma from a technical school (HF) / University of Applied Sciences (FH) or university

• Significant experience in a GMP-regulated environment, with regard to equipment qualification and validation, e.g. autoclaves, pure media, clean rooms, as well as process engineering equipment

• Practical experience in planning and executing Factory Acceptance Tests (FATs) / Site Acceptance Tests (SATs), qualifications and validations in a GMP environment

• Knowledge of Microsoft Office is required; knowledge of COMOS (Plant Engineering software solution) and SAP is an advantage

• English (fluent written/oral), German (good knowledge written/oral) advantageous

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.