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Senior Engineer Qualification

vor 2 Monaten


Leverkusen, Nordrhein-Westfalen, Deutschland Exyte Vollzeit
About the Role

We are seeking a highly skilled Senior Engineer Qualification & Validation to join our team at Exyte Central Europe. 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
  • Qualify equipment and facilities according to current GMP regulations in cleanrooms and media
  • Develop and implement qualification concepts for pharmaceutical plants
  • Create qualification & validation documents, test plans, and reports
  • 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
  • At least 4 years of professional experience in the life science industry with knowledge in qualification & validation and/or engineering and commissioning of process plants
  • Experience in project management and applying relevant technical knowledge and current regulations
  • Fluent German and good English skills
  • Proactive commitment to customers and quality-oriented work
What We Offer
  • Two-day onboarding event with new colleagues
  • Attractive location with spacious workstations and height-adjustable desks
  • Buddy-System for familiarization with colleagues
  • Work-life balance with possibility of mobile working
  • Catering and fitness contract subsidies