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Engineer Qualification

vor 2 Wochen

Nürnberg, Bayern, Deutschland Exyte GmbH Vollzeit 60.000 € - 90.000 € pro Jahr


Your vision is ambitious. Just like ours.

Our people are our success. As one of us, you will contribute to engineering excellence for the high-tech markets of the future, including semiconductors, batteries, pharmaceuticals, biotechnology, and data centers. At Exyte, you will be part of a global community of challenge seekers who are ambitious and passionate about innovation. Together, we will build on our company's long history and keep on leading the way to a better world.



Discover your exciting role

Join our team as a Engineer Qualification (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 regulations
  • Preparation 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 execution
  • Responsible 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 management
  • During 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 study
  • Relevant 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 required
  • Proactive 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 colleagues
  • Attractive location: Our location in Stuttgart features spacious workstations with height-adjustable desks
  • Buddy-System: Several weeks of close familiarisation with your colleagues in the team
  • Work-life balance: There is always the possibility of switching to mobile working
  • Catering: Free coffee specialities as well as water dispensers are accessible on every floor
  • Keep 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

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.



CONTACT:



Exyte is an Equal Employment Opportunity employer and is committed to equal opportunity and equal treatment. Therefore, Exyte Group provides equal employment opportunities to all qualified applicants regardless of ancestry, gender, sexual orientation, gender identity, race, color, religion, protected veteran or disability status, or genetic information.