Munich: Qualification Engineer (m/w/d) -

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

• 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).

• 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

• 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