CSV Engineer (m/w/d) Computersystemvalidierung in der Medizintechnik
EKF - diagnostic GmbH is an international specialist in in-vitro diagnostics, developing, manufacturing, and distributing blood analysis devices for medical diagnosis and use in clinical laboratories. As a mid-sized company, we value short communication paths and close collaboration between departments. Your responsibilities as a CSV engineer will include planning, executing, and monitoring qualifications/validations of computerized systems, creating qualification documents and validation plans, and participating in projects to change or introduce new systems. Additionally, you will support risk assessments (FMEA) and qualification/validation according to ISO 13485, GAMP 5, FDA 21 CFR Part 11/820, and EU GMP. Requirements for the role include a completed engineering or technical degree (preferably in medical technology, pharmaceutical technology, biotechnology, process engineering, computer science, etc.), knowledge in the validation/qualification of computerized systems in a GMP regulated environment, and desirable experience in project management and FMEA moderation techniques. Strong communication skills, conflict resolution abilities, structured work approach, and confident English language proficiency are also expected. We offer an interesting, diverse, and future-oriented work area with equal collaboration, as well as attractive compensation and benefits package (e.g., bike leasing). If this sounds like the right opportunity for you, we invite you to take on this challenge by submitting your complete and meaningful application documents, including salary expectations, earliest possible starting date, and reference number YF19768247. Full-time employment, permanent contract. Location: Ebendorfer Chaussee 3, 39179 Barleben. Contact: 039203/ 511 126; Ms. Bianca Schulze; www.ekfdiagnostics.de; bewerbung [AT]ekf-diagnostic.de.
