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Munich

Our client, a biotechnology company based in Munich and specializing in the development and marketing of immunologically active biopharmaceutical products, is looking for a:

Qualification Engineer (m/w/d)

Homeoffice: 1-2 days per week

Aufgaben

Your primary tasks include planning and executing the qualification of equipment, devices, systems, facilities, and associated software.
Conducting market research and obtaining quotes based on previously developed requirement specifications.
Independently preparing qualification documents, covering planning, execution, reporting, and tracking of deficiencies in coordination with relevant departments and suppliers.
Performing risk analyses, deriving necessary measures if applicable, and ensuring their implementation.
Preparing SOPs and work instructions.
Leading and organizing qualification projects, including training employees on equipment operation.
Ensuring compliance with applicable regulations (e.g., EU GMP Annex 15).

Qualifikation

Scientific education or university degree.
At least 5 years of experience in the pharmaceutical industry.
Extensive professional experience in equipment qualification and GMP-compliant documentation.
Profound knowledge of current GMP guidelines for the qualification of equipment, devices, and systems.
Experience in validating computerized systems in accordance with EU GMP Annex 11, 21 CFR Part 11, and GAMP 5.
Meticulous, conscientious, and team-oriented working style.
Initiative, commitment, high reliability, and independence.
Service-oriented approach and focus on customer satisfaction.
Language skills: German C1 - English B2

Benefits

Homeoffice: 1-2 days per week
A diverse work environment
Flexible working hours (flexible working time models, 37.5 hours/week, home office).
Attractive remuneration, 30 vacation days, and various social benefits.

Contact:

Mariana Chaumont
Senior Consultant
+49 (0)89 80913072-0