Engineer Qualification (m/w/d)

Overview

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.

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

Qualifications

• 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

• Your start at Exyte: Take part in a two-day onboarding event with new colleagues
• Attractive location: Our location 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 Qualitrain at over 5,000 locations in Germany

Contact

Would you like to become part of the Exyte team? Then we look forward to your application! For questions and further information, please contact Katharina Hermann by email at Exyte Management GmbH, Katharina Hermann, Löwentorstrasse 42, 70376 Stuttgart

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.

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Engineering and Information Technology

Industries

• Civil Engineering

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