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 Production and Manufacturing Execution 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 Senior Validation Management 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 (min. C1 level) and have 2-5 years of experience in Computer Systems Validation area.
- Bachelor’s Degree; preferably in engineering, sciences, pharmaceuticals or biotechnology or equivalent and longstanding professional experience in regulations and processes.
- Good analytical capabilities and problem-solving competence including a proper understanding of prioritization.
- 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.
- Experience in Production & Manufacturing (e.g. MES, PAS-X or SAP PP-PI or similar).
- Experience in Label management and Product Safety & Security (PSS) would be an advantage.
- Good Knowledge of GxP (Good Practices) regulations, especially within the Pharmaceutical Industry would be a plus.
- Experience with agile methods (e.g. SCRUM, Kanban) and tools (e.g. JIRA) would be an advantage.
- Dedicated team player with good communication skills, and a structured way of working.
- Experience in a pharmaceutical or biopharmaceutical production or supporting areas (e.g. quality assurance in production) is nice to have.
