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 to manage Boehringer Ingelheim’s global eSignature Solution according to our validation rules, incl. evaluating process & system changes, proposing solutions and taking the necessary steps to implement them. You are working 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 Process Expert for Contracting Solutions you will be able to coordinate and propose solutions within the Demand Management process, as well as actively take part of Change and Release Management.
Tasks & responsibilities
- As Process Expert you are responsible for managing Boehringer Ingelheim’s global eSignature Solution in accordance with our validation rules, collaborating closely with the Validation Manager and the CSV&C function.
- Perform analysis and detailed assessment of all changes (updates, bug fixes, new functionality) to identify GxP relevant items.
- Work with the Service Supplier to resolve bug fixes and implement change requests, documenting change summaries and all relevant documentation.
- Manage, execute, and document changes in the application.
- Create and maintain training materials.
- Design and execute required regression tests and related documentation.
- Author validation documents such as User Requirements, Risk Assessments, Configuration Requirements, VVP, Test Cases, Traceability Matrices, and others.
- Consult our global user base on the Signature solution, evaluating new requirements while considering local eSignature regulations (e.g., usage of ID NOW).
- Participate in projects driven by Agile methods and tools.
- Commit to continuous learning and upskilling, providing consultation to Validation Managers regarding various service providers and implementation strategies.
- Assist in internal and external audits.
About our future employee
- Bachelor’s degree in business informatics, Engineering, IT, or a related field with strong technical affinity.
- Technical affinity to eSignature Solutions (DocuSign, Adobe Sign, etc.) and comprehensive knowledge of eSignature regulations (e.g., QES, eIDAS, ICP Brazil).
- Excellent communication skills in English and a structured way of working.
- Strong analytical capabilities and problem-solving skills, with a good understanding of prioritization.
- Knowledge and understanding of Computer Systems Validation (CSV) regulations, including GAMP5, 21 CFR Part 11, CSA framework, EU Annex 11, and Data Integrity regulations is a plus.