Munich: Qualification Engineer (m/w/d)

Our clinet, a biotech company specializing in the development and marketing of immunologically active biopharmaceutical products, is looking for a:

Qualification Engineer (m/w/d)
Location: Munich
Homeoffice: 1-2 days per week

Your responsibilities:

• 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).

Requirements:

• 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

What the company offers:

• 1-2 days Homeoffice per week
• a dynamic working environment in the biotech industry, with opportunities to shape your role and make decisions quickly.
• flexible working hours (flex-time models, 37.5 hours/week)
• attractive remuneration
• 30 days of vacation
• various social benefits.

Contact:

Mariana Chaumont
Senior Consultant
chaumont@triga-consulting.de
+49 (0)89 80913072-0