Job Overview
Join to apply for the Global Validation Expert role at Boehringer Ingelheim. This position supports the digital transformation in our laboratories, leading the validation of global IT systems for laboratory instrument integration and data management. You will contribute to the future of laboratory science, enhance our internal processes, and be part of industry‑wide innovation.
Tasks and Responsibilities
* Develop Validation Strategies: Create and implement validation strategies, define processes, and set timelines for validation activities.
* Support Validation Activities: Ensure all validation activities are conducted according to defined strategies, review protocols, and oversee testing procedures.
* Ensure Compliance with Regulations: Validate computer systems in compliance with regulations and adapt strategies as necessary.
* Documentation and Reporting: Maintain documentation of all activities, prepare reports, document issues and resolutions, and maintain records.
* Training and Development: Participate in training and development on validation processes and provide support to the team.
Requirements
* Education: Bachelor's degree in IT, Bioinformatics, Medicinal Informatics, or similar.
* Experience: Minimum 4 years in computer systems validation management (or related field). Extensive experience in creating validation concepts for global systems from ground up and representing systems in audits and inspections.
* Technical IT Understanding: Solid understanding of the technology being validated, including hardware, software, and network systems.
* Regulatory Knowledge: Expertise in relevant regulations and standards for computer system validation, such as FDA 21 CFR Part 11 and EU Annex 11.
* Communication: Ability to effectively communicate with team members and stakeholders.
* Documentation Skills: Highly skilled in preparing accurate validation documentation and reports.
* Language skills: English and Spanish, additional languages are a plus.
Benefits
* Flexible working conditions
* Life and accident insurance
* Health insurance at a competitive price
* Investment in your learning and development
* Gym membership discounts
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, you’ll be helping to transform lives for generations.
Want to learn more? Visit https://www.boehringer-ingelheim.com
Seniority Level
Mid-Senior level
Employment Type
Full-time
Job Function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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