Description
Discover your exciting role
Join our team as a Engineer Qualification - Equipment and Process (m/f/d) and take responsibility for GMP-compliant qualification activities, supplier coordination, and cross-functional communication.
Explore Your Tasks And Responsibilities
Responsible handling of project-specific qualification and validation activities according to current GMP regulationsPreparation and review of qualification & validation documents (specifications, risk analysis, plans and reports)Preparation of test protocols for different qualification stages (DQ, IQ, OQ, PQ) and being responsible for their executionResponsible for supplier coordination and review of supplier documentation(FAT/ SAT, technical documents)Responsible for the communication between qualification, customer/user, technical engineers, automation, QA, and suppliers as well as reporting to the CQV manager /project managementDuring the implementation phase, you are on-site to coordinate and conduct the qualification independently. You are able to work under time pressure and to successfully drive the project forward
Show Your Expertise
Completed studies in the field of biotechnology, pharmaceutical or process engineering, medical devices or a related field of studyRelevant technical knowledge of current regulations in qualification and validation (GMP, ISO, 21 CFR, Annex 15, data integrity)You have gained a first insight into qualification/validation during your first job or during an internship (ideally in the life sciences industry)Fluent written and oral communication skills in English. Good German skills are requiredProactive and independent working style as well as a high level of quality awareness, efficiency and accuracy
What We Offer You
Your start at Exyte: Take part in a two-day onboarding event with new colleaguesAttractive location: Our location in Stuttgart features spacious workstations with height-adjustable desksBuddy-System: Several weeks of close familiarisation with your colleagues in the teamWork-life balance: There is always the possibility of switching to mobile workingCatering: Free coffee specialities as well as water dispensers are accessible on every floorKeep fit: Exyte subsidises your fitness contract through Egym Wellpass at over 5,000 locations in Germany
Contact
You want to be part of the Exyte team? We look forward to receiving your application!
For further questions and information, please do not hesitate to contact Katharina Hermann via E-Mail at
[email protected]
Please note that we only consider applications submitted through our application portal. Applications sent via email will not be considered due to data protection regulations.