Qualification Engineer New Construction Production (m/f/d)

As part of our project for the construction of a GMP-compliant pharmaceutical production facility, you act as a project team member of the qualification group. You work in an interdisciplinary team with internal specialist departments and external service providers and thus contribute significantly to the success of the project. You accompany the new building project as Subject Matter Expert (SME) for the qualification over the entire life cycle – from the concept phase to the basic and detail engineering to the commissioning and qualification of the plants. You examine and evaluate planning documents such as radio specifications, layout plans, R&I flow schemes and qualification and validation documents from external service providers. You independently prepare request and qualification documents, risk analyses and SOPs in consultation with the departments and suppliers, if necessary, carry out necessary measures and pursue their processing independently. You are responsible for ensuring compliance with valid guidelines in the relevant field (e.g. EU GMP); US FDA Guidelines, etc.).

Natural science training or studies At least 5 years of experience in the pharmaceutical environment Comprehensive professional experience in equipment/plant qualification and GMP-compliant documentation Knowledge of current GMP guidelines for the qualification of equipment, equipment, equipment and their systems Experiences in project management are advantageous Experience in the validation of computerised systems by EU GMP and GAMP Careful, conscientious, strong and team-oriented working Self-initiative, readiness to perform, high reliability and independence Service orientation and focus on customer satisfaction Very good German (CEF C1) and good English (CEF B2)

We offer a varied working environment in the biotech sector with free spaces for design and short distances. In addition, we offer flexible working hours (consultation period, 37.5 hours/week), attractive remuneration, 30 days of leave and various social benefits. .