**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 Demand to Deploy. 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 daily. You will be equipped to actively contribute within a cross-functional team and serve as a Senior Process Specialist throughout the lifecycle of computer systems that support quality processes. This includes initiating and analyzing change requests, performing impact analyses, creating documentation and testing, to ensure the computer systems remain in a validated state. **Tasks & responsibilities** • Act as a Senior Process Specialist (process subject matter expert), supporting daily validation activities of quality-related computer systems, in line with global procedures. • Ensure computer systems remain validated and supported processes remain compliant by maintaining System Lifecycle documentation, including change requests, impact assessments, test definitions and execution (as required by complexity), test summary reports, and updated training materials. • Leverage your expertise in Computer System Validation to ensure changes are assessed in compliance with validation requirements, in close collaboration with other experts. • Participate in Agile-driven projects, applying relevant methods and tools effectively. • Work within project frameworks that are measured by KPIs and SLAs, continuously identifying and implementing improvement opportunities. **About our future employee** You should speak English fluently (min. C1 level) and have at least 5 years of experience in the QA field, preferably within the medical or pharmaceutical sector. **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. • Extensive experience across multiple quality domains, including Design Control of Medical Devices, Computer System Validation, Data Integrity, Equipment Validation, Process Validation, Cleaning Validation, Control Strategy, Quality Risk Management and/or Annual Product Review. • Profound knowledge and understanding of Computer Systems Validation regulation (CSV), including GAMP5, 21CFR Part 11, FDA CSA framework, and EU Annex 11, and Data Integrity would be a plus. • Hands-on experience in Computer Systems such as Trackwise, Valgenesis, Kneat, Doors, Polarion, HP ALM. • Experience with agile methods (e.g., SCRUM, Kanban) and tools (e.g., JIRA, Confluence) 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.