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Senior Validation Specialist
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Senior Validation Engineer
vor 2 Monaten
About Exyte
Exyte is a global leader in design, engineering, and delivery of facilities for high-tech industries. Our mission is to serve people and planet by energy saving and more sustainable engineering.
Job Summary
We are seeking a highly skilled Senior Validation Engineer to join our team at Exyte Central Europe. As a Senior Validation Engineer, you will be responsible for handling project-specific qualification and validation activities according to current GMP regulations.
Key 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
Requirements
- 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 E Gym Wellpass at over 5,000 locations in Germany