Validation Engineer (m/w/x)

Trust something new, grow beyond itself and redefine the boundaries of the feasible. That is exactly what our employees can and should live daily. To set the pace with our innovations and make it great. Because there are a lot of fascinating people behind every successful company. ZEISS employees work in an open and modern environment with numerous development and further training opportunities. Our culture is characterized by expert knowledge and team spirit. All this is supported by the special ownership structure and the long-term goal of the Carl-Zeiss Foundation: to advance science and society together.

Today dare. Inspire tomorrow.

Diversity is part of ZEISS. We look forward to your application regardless of gender, nationality, ethnic and social origin, religion, world view, disability, age as well as sexual orientation and identity.

Apply now! In less than 10 minutes. Seeing beyond - future of medical technology

For more than 100 years, the medical technology of ZEISS has been driving progress in ophthalmology and microsurgery. In ophthalmology, our solutions help to maintain and improve the vision of people at any time of life. In microsurgery, our solutions enable targeted interventions on the diseased tissue, so that small and sensitive organs continue to function optimally.

ZEISS's medical technology supports medical professionals to improve the lives of patients worldwide. The fact that we have a direct influence on the well-being of our people is our daily drive.

Implementation of qualifications of production and testing equipment and validation of production and testing processes within the assembly of medical technology products

Planning and carrying out training and validation activities for computer-assisted systems, in the field of production medical technology

Implementation of revalidations and project-related qualification / validation measures

Deviations in the course of qualification/validation and processing until the completion of the measures

Creating, performing and moderating error options and influence analyses (process-FMEA)

Prepare test plans and reports (FAT/SAT, DQ, IQ, OQ, PQ)

Working with the continuous development and efficiency increase of the validation processes

well-founded experience in the field of process and method validation /-qualification in the context of medical technology and can work independently and independently according to GMP requirements

ideally experience in software validation (GAMP, GMP)

well-founded knowledge of FMEA methodology and FMEA software, preferably with APIS IQ software

good statistical knowledge (Six Sigma or ISO 22514-7) and a routined application of MS Office tools

systematic and analytical approach as well as a high degree of initiative and willingness to take responsibility

a pronounced social competence, flexibility and team capacity

good knowledge of German and English in word and writing

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