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Lead Engineer Qualification Specialist

vor 2 Monaten


Penzberg, Bayern, Deutschland Exyte Vollzeit
About the Role

We are seeking a highly skilled and experienced Lead Engineer Qualification Specialist to join our team at Exyte. As a key member of our Bio Life Sciences sector, you will be responsible for handling project-specific qualification and validation activities, overseeing GMP consulting, and creating qualification & validation documents.

Key Responsibilities
  • Develop and implement qualification concepts for pharmaceutical plants and facilities.
  • Execute and coordinate GxP reviews and risk analyses.
  • Act as the interface between qualification, technical engineers, suppliers, and project management.
  • Assess and implement change and deviation management (CAPA) and track and monitor CAPA.
Requirements
  • Completed studies in biotechnology, food technology, pharmaceutical, or medical technology or a related field of study.
  • 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.
  • Experience in project management and applying relevant technical knowledge and current regulations.
  • Fluent German and good English skills.
  • Proactive commitment to customers and a quality-oriented and independent way of working.
What We Offer
  • Onboarding program with new colleagues.
  • Interesting projects with high-modern and high-complex pharmaceutical plants.
  • Attractive location with spacious workstations and adjustable desks.
  • Buddy system with a comprehensive onboarding phase.
  • Work-life balance with the possibility of mobile work.
  • Free coffee specialties and water dispensers on every floor.
  • Exyte subsidizes fitness contracts through EGym Wellpass at over 5,000 locations in Germany.