Job Description

Joining our company, you will gather an overview of the GBS Enabling Services Organization with a particular focus on the tasks and responsibilities of Validation Management. 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 daily.

You will be equipped to actively contribute within a cross-functional team and serve as a Validation Specialist throughout the lifecycle of computer systems that support quality processes. This includes managing change requests, reviewing impact analyses and approving documentation, ensuring the computer systems remain in a validated state.

Tasks & Responsibilities

• Act as a Validation Management Specialist, supporting daily validation activities of quality-related computer systems, in line with global procedures.
• Ensure Computer Systems remain compliant and in a validated state by overseeing the System Lifecycle documentation and testing of computer systems.
• Leverage your expertise in Computer System Validation to ensure changes are managed in compliance with validation requirements, and in close collaboration with 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 around 2-4 years of experience in validation/QA area.

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.
• Hands-on experience in electronic Quality Management Systems (TrackWise, Veeva) and/or related pharma experience (Quality Management).
• Profound knowledge and understanding of Computer Systems Validation regulation (CSV), including GAMP5, 21CFR Part 11, FDA CSA framework, EU Annex 11, and Data Integrity.
• Good Knowledge of GxP (Good Practices) regulations within the Pharmaceutical Industry.
• 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.

Why Boehringer Ingelheim?

With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, youll be helping to transform lives for generations.