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Lead Engineer Qualification Specialist
vor 2 Monaten
At Exyte, we're driven by a shared vision of innovation and excellence. As a Lead Engineer Qualification, you'll be part of a global community of challenge seekers who are passionate about shaping the future of high-tech markets, including semiconductors, batteries, pharmaceuticals, biotechnology, and data centers.
Your RoleAs a key member of our Bio Life Sciences sector at Exyte Central Europe, you'll report to the Group Lead Qualification and work in our regional office in Penzberg. Your primary focus will be on qualifying equipment and facilities for our clients on-site, collaborating with a team of highly qualified and experienced qualification & validation engineers. You'll cover projects mainly within Germany, with the possibility of mobile working depending on the project.
Your Responsibilities- Develop and implement qualification concepts for pharmaceutical plants, ensuring compliance with current GMP regulations in cleanrooms and media.
- Oversee GMP consulting for the planning of pharmaceutical plants and create qualification & validation documents, test plans, and reports (FAT/SAT, DQ, IQ, OQ, PQ).
- Execute and coordinate GxP reviews and risk analyses, acting as the interface between qualification, technical engineers, suppliers, and project management.
- Assess and implement change and deviation management (CAPA) as well as CAPA tracking and monitoring.
- You hold a degree in biotechnology, food technology, pharmaceutical, or medical technology, or a related field of study.
- You have at least 4 years of professional experience in the life science industry, with profound knowledge in qualification & validation and/or engineering and commissioning of process plants/clean rooms/media systems.
- You're experienced in project management and applying relevant technical knowledge and current regulations.
- You speak German fluently and have good English skills.
- You're proactive, committed to customers, and have a quality-oriented and independent way of working.
- A comprehensive onboarding program to ensure a smooth start.
- Exciting projects, including participation in a flagship project in the industry, creating modern and complex pharmaceutical plants.
- An attractive work environment with spacious offices and adjustable workstations.
- A buddy system for a smooth integration into the team.
- The possibility of mobile working, allowing for a better work-life balance.
- Catering services, including free coffee specialties and water dispensers on every floor.
- A fitness program, with Exyte subsidizing your fitness contract through EGym.
We're an Equal Employment Opportunity employer, committed to equal opportunity and equal treatment. We welcome applications from all qualified candidates, regardless of ancestry, gender, sexual orientation, gender identity, race, color, religion, protected veteran or disability status, or genetic information.
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