Qualification Engineer (m/w/d)

Plan, coordinate, and independently conduct qualification activities such as FAT and SAT for equipment and systems

Create, maintain, and verify qualification-related documentation

Conduct installation and functional tests, evaluate results, and derive appropriate measures

Ensure compliance with GMP, GAMP, as well as internal quality and documentation standards

Work closely with internal departments and clients to meet FAT and SAT documentation requirements

Support handling deviations, CAPA measures, and requalification activities

Contribute to the continuous optimisation of qualification processes and best practices

Degree in a scientific or technical field, e.g., process engineering or biotechnology

Several years of relevant professional experience in qualification, validation or engineering

In-depth knowledge of GMP requirements and qualification principles

Understanding of upstream and downstream process technology as well as automation and control technology

Proficient use of Adobe Acrobat, MS Office, and documentation tools

Experience with SAP, ideally also with KNEAT

Structured, independent, and quality-oriented working style

Strong communication and coordination skills as well as enjoyment of interdisciplinary teamwork

Good English skills and proficient German in both written and spoken form

Analytical thinking and high quality awareness