Validation Engineer - Clinical Data Hub - Remote

Overview

As a Validation Engineer at Amgen, you will play a pivotal role in modernizing the regulatory submission process and ensuring compliance in the management of data validation processes.

In Short

• Join a mission-driven team at Amgen.
• Focus on regulatory submission and Clinical Data Hub platform.
• Develop test plans and strategies based on project specifications.
• Perform manual and automated testing of software applications.
• Document and report defects, collaborating with development teams.
• Ensure compliance with regulatory requirements.
• Enhance testing efficiency and adopt new tools.
• Stay informed on industry trends and regulatory updates.
• Provide expert technical support in validation.
• Work effectively in a dynamic environment.

Requirements

• Master's or Bachelor's degree with 5 to 9 years of experience.
• Excellent problem-solving skills and experience with Agile methodologies.
• Proficiency in automation tools and validation software.
• Strong understanding of GxP guidelines and regulatory compliance.
• Ability to communicate effectively with senior leadership.
• Experience in writing requirements for web application development.
• Familiarity with low-code, no-code test automation software.
• Strong analytical and decision-making abilities.
• Ability to manage multiple priorities successfully.
• Professional certifications such as SAFe for Teams are preferred.

Benefits

• Competitive and comprehensive Total Rewards Plans.
• Support for professional and personal growth.
• Collaborative culture focused on innovation.
• Opportunities for mentorship and team collaboration.
• Work in a company dedicated to improving quality of life.