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Senior Engineer Qualification

vor 2 Monaten


Leverkusen, Nordrhein-Westfalen, Deutschland Exyte Vollzeit

About Exyte

Exyte is a global leader in the design, engineering, and delivery of complex pharmaceutical plants and facilities.

Job Summary

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 according to current GMP regulations in cleanrooms and media.

Key Responsibilities

  • Oversee the 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.
  • Willing 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.