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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 an MDM Senior Validation Specialist, 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 a Validation Management Specialist, you support our daily operation of processes and applications
• You 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 and have broad experience in Validation Management, ideally in Computer Systems Validation (CSV).

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
• Profound experience in a pharmaceutical or biopharmaceutical production or supporting areas (e.g. quality assurance in production) required
• A strong understanding of pharmaceutical regulations, including those mandated by the FDA, ICH, and European Pharmacopoeia
• 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 ERP systems (e.g. SAP) is required
• Experience with Veeva Network would be an asset
• 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
  
  
  

Our Company

Why Boehringer Ingelheim?

With us, you can develop your own path in a company with a culture that knows our differences are our strengths \u2013 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 \u2013 as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Want to learn more? Visit https://www.boehringer-ingelheim.com