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Engineer - Computerized System Validation Expert (m/f/d)

Posted on Nov 23, 2019 by MorphoSys AG

München, Bayern, Germany
Engineering
Immediate Start
Annual Salary
Full-Time
MorphoSys' mission is to make exceptional, innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases. Innovative technologies and smart development strategies are central to our approach. Success is created by our people, who focus on excellence in all they do, collaborate closely across disciplines. We all are driven by a desire to make the medicines of tomorrow a reality. Guided by mutual respect and trust, each member of the MorphoSys team is given the opportunity to develop and flourish within this exciting and inspiring environment. Join us in Planegg near Munich!

We would like to fill the following vacancy as soon as possible: Computerized System Validation Expert (gn)
  • Active support in the conception, implementation and operation of validation measures along pharmaceutical processes and taking into account quality, cost and timeline requirements
  • The integration of stakeholders from different functions and 3rd parties is part of your tasks
  • Participate as SME to the URS preparation: You support the project team in the analysis of customer requirements and the creation of solution concepts for later implementation and changes
  • Perform impact and risk assessments, design and prepare qualification / validation documents (incl. test management)
  • Maintain the validation status of existing computerized systems according to a predefined frequency and in accordance with current internal SOPs
  • Ensure compliance of the validation standards of the computerized systems through the continuous updating of procedures, according to international regulation and standards (GxP, GAMP5)
  • Create and maintain of Qualification documents (Network, Servers, Operating Systems, Databases) and oversee end-to-end process enforcement in the GxP environment
  • Ensure Infrastructure (Network, Servers, Database) Qualification documents are created, updated and reviewed on the defined Quality standards and on time on the regular bases
  • Several years of professional experience in computerized system validation (CSV) in several projects
  • Experience in the development of validation plans and their implementation and know how to find and implement viable solutions in an environment of competing interests
  • Practical experience in the application of relevant regulations (EMA, FDA, OECD etc.) and know how to derive practicable measures according to GAMP5
  • Good understanding of GAMP processes
  • Ability to write clear documentation and communicate complex information simply and accurately to both technical and non-technical audiences
  • Creative working in X-functional teams
  • Open and appreciative corporate culture
  • Multicultural environment
  • Working in an attractive, high-quality equipped building with restaurant
  • Free sports and language courses

Reference: 800739703

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