Senior Engineer Qualification
vor 3 Wochen
At Exyte, we're committed to excellence in engineering and innovation. As a Senior Engineer Qualification & Validation, you'll play a crucial role in ensuring the highest standards of quality and compliance in our pharmaceutical plants and facilities.
Your Key Responsibilities:- Lead qualification and validation activities for projects, ensuring adherence to current GMP regulations in cleanrooms and media.
- Oversee GMP consulting for the planning of pharmaceutical plants and develop qualification concepts.
- Create qualification & validation documents, test plans, and reports, and execute and coordinate GxP reviews and risk analyses.
- Act as the interface between qualification, technical engineers, suppliers, and report to customers and project management.
- Assess and implement change and deviation management (CAPA) and track and monitor CAPA.
- A degree in biotechnology, food technology, pharmaceutical, or medical technology, or a related field.
- At least 4 years of professional experience in the life science industry, with a strong background in qualification & validation and/or engineering and commissioning of process plants/clean rooms/media systems.
- Experience in project management and applying relevant technical knowledge and current regulations.
- Fluent German and good English skills.
- A proactive commitment to customers, quality-oriented, and independent work style.
- Will to work on-site with clients.
- 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.
- Subsidized fitness contracts through Qualitrain at over 5,000 locations in Germany.
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