- You are responsible for handling the project-specific qualification and validation activities according to current GMP regulations in cleanrooms and media
- You oversee the GMP consulting for the planning of pharmaceutical plants and the development and implementation of qualification concepts
- You create qualification & validation documents, test plans and reports (FAT/ SAT, DQ, IQ, OQ, PQ) and you execute and coordinate GxP reviews and risk analyses
- You act as the interface between qualification, technical engineers, suppliers and report to the customer as well as project management
- You are responsible for the assessment and implementation of change and deviation management (CAPA) as well as CAPA tracking and monitoring
- You 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
- 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 German
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Lead Engineer Qualification - Leverkusen, Deutschland - Exyte
Beschreibung
Your vision is ambitious
. Just like ours.Our people are our success. As one of us, you will contribute to engineering excellence for the high-tech markets of the future, including semiconductors, batteries, pharmaceuticals, biotechnology, and data centers. At Exyte, you will be part of a global community of challenge seekers who are ambitious and passionate about innovation. Together, we will build on our company's long history and keep on leading the way to a better world.
Discover your exciting role
Exyte is a global leader in the design, engineering and delivery of complex pharmaceutical plants and facilities.
As Senior Engineer Qualification & Validation (m/f/d), you work in the Bio Life Sciences sector at Exyte Central Europe and report to the Group Lead Qualification & Validation (m/f/d). You are going to work in our regional office in Leverkusen, Stuttgart, Nürnberg or Penzberg and mainly with our clients on-site to qualify the respective equipment and facilities. In a team of highly qualified and experienced qualification & validation engineers you will be covering projects mainly within Germany. Mobile working is also a possibility, depending on the project.
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Exyte is an Equal Employment Opportunity employer and is committed to equal opportunity and equal treatment. Therefore, Exyte Group provides equal employment opportunities to all qualified applicants regardless of ancestry, gender, sexual orientation, gender identity, race, color, religion, protected veteran or disability status, or genetic information.
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