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Senior Engineer Qualification
vor 1 Monat
Unlock Your Expertise
As a Senior Engineer Qualification & Validation at Exyte, you will be part of a global community of challenge seekers who are ambitious and passionate about innovation. Your vision is ambitious, just like ours. You will contribute to engineering excellence for the high-tech markets of the future, including semiconductors, batteries, pharmaceuticals, biotechnology, and data centers.
Discover Your Role
Exyte is a global leader in the design, engineering, and delivery of complex pharmaceutical plants and facilities. As a Senior Engineer Qualification & Validation, you will work in the Bio Life Sciences sector at Exyte Central Europe and report to the Group Lead Qualification & Validation. You will be based in our regional office in Leverkusen, Stuttgart, N"urnberg, or Penzberg and will mainly work with our clients on-site to qualify the respective equipment and facilities.
Explore Your Responsibilities
- You will be responsible for handling project-specific qualification and validation activities according to current GMP regulations in cleanrooms and media.
- You will oversee the GMP consulting for the planning of pharmaceutical plants and the development and implementation of qualification concepts.
- You will create qualification & validation documents, test plans, and reports (FAT/SAT, DQ, IQ, OQ, PQ) and execute and coordinate GxP reviews and risk analyses.
- You will act as the interface between qualification, technical engineers, suppliers, and report to the customer as well as project management.
- You will be responsible for the assessment and implementation of change and deviation management (CAPA) as well as CAPA tracking and monitoring.
Show Your Expertise
- You have completed your studies in the field of biotechnology, food technology, pharmaceutical, or medical technology or a related field of study successfully.
- 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 are experienced in project management and in applying the relevant technical knowledge and current regulations.
- You speak German fluently and your English skills are good.
- Proactive commitment to customers as well as a quality-oriented and independent way of working are self-evidently to you.
- You are willing to work on-site with our clients.
What We Offer You
- 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.
