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Senior Validation Engineer
vor 1 Monat
Unlock Your Potential
As a Senior Validation Engineer at Exyte, you will play a crucial role in ensuring the quality and compliance of our clients' facilities. Your expertise in qualification and validation will be instrumental in driving our company's success in the high-tech industry.
About the Role
- Lead qualification and validation activities for various projects, ensuring adherence to current GMP regulations.
- Develop and review qualification and validation documents, including specifications, risk analyses, plans, and reports.
- Prepare and execute test protocols for different qualification stages (DQ, IQ, OQ, PQ).
- Coordinate with suppliers and review their documentation (FAT/SAT, technical documents).
- Communicate effectively with qualification, customer/user, technical engineers, automation, QA, and suppliers, and report to the CQV manager/project management.
- Work independently on-site during the implementation phase, coordinating and conducting qualification activities under time pressure.
Requirements
- Completed studies in biotechnology, pharmaceutical, or process engineering, medical devices, or a related field.
- Relevant technical knowledge of current regulations in qualification and validation (GMP, ISO, 21 CFR, Annex 15, data integrity).
- Experience in qualification/validation, ideally in the life sciences industry.
- Fluent written and oral communication skills in English, with good German skills.
- Proactive and independent working style, with a high level of quality awareness, efficiency, and accuracy.
What We Offer
- A two-day onboarding event with new colleagues.
- An attractive location with spacious workstations and height-adjustable desks.
- A buddy system for familiarization with colleagues in the team.
- Work-life balance with the possibility of mobile working.
- Catering with free coffee specialties and water dispensers on every floor.
- Subsidized fitness contracts through E Gym Wellpass at over 5,000 locations in Germany.
