Lead Engineer Qualification / Validation (m/f/d)

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.

Explore your tasks and responsibilities

• 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

Show your expertise

• 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

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 German