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Validation Specialist
3 months ago
- Understanding of software development lifecycle models and experience with business/end-user applications.
- Strong knowledge in validation principles and practices in a GMP environment. Experience in validating digital solutions, including Release Management processes and controls, as well as validation of statistical and data-driven models. Familiar with test automation process and development.
- Experience in managing infrastructure through multiple product releases, and have passion for reliability and security. Work with management to set priorities, track operational metrics.
- Demonstrate knowledge of current GxP requirements and documentation standards with the ability to write validation docs.
- Knowledge of pharma and/or cell & gene therapy supply chain processes is a plus.
- Displays skills and capabilities in the area of business partnering and/ or product management.
- Proactively lead the validation efforts throughout the E2E process and work in a cross-functional and global team.
- Demonstrates ability to perform detail-oriented work with a high degree of accuracy and able to explain complex concepts with clarity and simplicity.
- Demonstrates ability to identify, troubleshoot and resolve issues quickly and effectively. Positive attitude and high energy with exceptional cross-group collaboration working with partner teams
- Possess a combination of analytical thinking, hands-on problem-solving, and a customer-service mindset Experience in ServiceNow and Google Cloud and AWS technologies
