**The position** Joining our company, you will gather an overview of the GBS Enabling Services Organization with a particular focus on the tasks and responsibilities from Validation Management. You will work in a globally operating team that designs, builds and continuously improves Boehringer Ingelheim’s global Processes, using agile principles, methods and tools on a daily basis. You will be qualified to contribute to a cross-functional team, and as a Senior Validation Specialist in the area of Quality Management you will be able to coordinate the activities around change requests, performing impact analysis, reviewing, and approving documents and ensuring a validated state of the system. **Tasks & responsibilities** + Based on your expertise in Computer System Validation, you ensure that changes are managed according to our validation rules in close cooperation with local experts in our GBS user community. + Acting as Validation Management Senior Specialist, you support our daily operation of processes and applications. + Ensure that our processes and systems are always compliant and in a validated state. + Furthermore, you manage the execution and documentation of testing activities. + As part of cross-functional teams, you ensure the implementation and continuous improvement of our standardized processes in global projects. + You are familiar with Agile methods and tools, participating to projects driven with this methodology. + You are familiar with working in projects and being measured against Key Performance Indicators (KPIs) / Service Level Agreements (SLAs) to strive for continuous improvement measures. **About our future Employee** You should speak English fluently, have experience in validation management (ideally in CSV) and quality management. **Additionally, we are looking for:** + Bachelor’s Degree; preferably in engineering, sciences, pharmaceuticals or biotechnology or equivalent and longstanding professional experience in regulations and processes. + Good SAP knowledge (especially SAP QM). + Profound experience in a pharmaceutical or biopharmaceutical production or supporting areas (e.g. quality assurance in production) would be an advantage. + A strong understanding of pharmaceutical regulations, including those mandated by the FDA, ICH, and European Pharmacopoeia would be an advantage. + Profound knowledge and understanding of Computer Systems Validation regulation (CSV), including GAMP5, 21 CFR Part 11, CSA framework and EU Annex 11, and Data Integrity regulation would be an advantage. + Experience with agile methods (e.g. SCRUM, Kanban) and tools (e.g. JIRA) would be an advantage. + Good analytical capabilities and problem-solving competence including a proper understanding of prioritization. + Dedicated team player with good communication skills, and a structured way of working. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.