Global Validation Expert
Global Validation Expert
Join us at Boehringer Ingelheim and support the digital transformation in our laboratories. As our Global Validation Expert, you'll lead the validation of global IT systems for laboratory instrument integration and data management. This is your chance to 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.
#IamBoehringerIngelheim because…
We are continuously working to design the best experience for you. Here are some examples of how we will take care of you:
- Flexible working conditions
- Life and accident insurance
- Health insurance at a competitive price
- Investment in your learning and development
- Gym membership discounts
If you have read this far, what are you waiting for to apply? We want to know more about you!