Senior Engineer Qualification

Vor 2 Tagen

Leverkusen, Nordrhein-Westfalen, Deutschland Exyte Vollzeit
{"title": "Senior Engineer Qualification & Validation", "content": "Unlock Your Potential

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. Our people are our success, and we are looking for talented individuals to contribute to engineering excellence for the high-tech markets of the future.

Key Responsibilities
  • Handle project-specific qualification and validation activities according to current GMP regulations in cleanrooms and media.
  • Oversee GMP consulting for the planning of pharmaceutical plants and the development and implementation of qualification concepts.
  • Create qualification & validation documents, test plans, and reports (FAT/SAT, DQ, IQ, OQ, PQ) and execute and coordinate GxP reviews and risk analyses.
  • Act as the interface between qualification, technical engineers, suppliers, and report to the customer as well as project management.
  • Assess and implement change and deviation management (CAPA) as well as CAPA tracking and monitoring.
Requirements
  • Completed studies in the field of biotechnology, food technology, pharmaceutical, or medical technology or a related field of study successfully.
  • 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.
  • Experienced in project management and in applying the relevant technical knowledge and current regulations.
  • Fluent in German and good English skills.
  • Proactive commitment to customers as well as a quality-oriented and independent way of working.
  • Will to work on-site with our clients.
What We Offer
  • 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.
", "lang_code": "en"}

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