Validation Engineer I - Remote

Overview

As a Validation Engineer I at Amgen, you will play a crucial role in ensuring compliance and innovation in data validation processes within the pharmaceutical industry, working closely with developers and business analysts.

In Short

• Join a mission-driven team at Amgen focused on serving patients.
• Work on GxP platforms for regulatory submission and clinical trial systems.
• Develop comprehensive test plans and strategies.
• Perform manual and automated testing of software applications.
• Document and report defects, collaborating with development teams.
• Ensure compliance with regulatory requirements.
• Identify opportunities for testing efficiency improvements.
• Stay informed on industry trends and regulatory updates.
• Provide expert technical support in validation.
• Support continuous improvements and automation within the program.

Requirements

• Master’s or Bachelor’s degree in Life Science/Biotechnology/Pharmacology/Information Systems.
• 1-5 years of relevant experience in the pharmaceutical industry.
• Experience in GxP validation processes.
• Excellent problem-solving and communication skills.
• Familiarity with Agile software development methodologies.
• Strong understanding of GAMP 5 guidelines and regulatory standards.
• Proficiency in automation tools and validation software.
• Experience with clinical trial registry and regulatory submission systems is preferred.
• Professional certifications like SAFe for Teams are a plus.
• Ability to work effectively with global teams.

Benefits

• Competitive salary and comprehensive Total Rewards Plans.
• Support for professional and personal growth.
• Collaborative and innovative work culture.
• Inclusive environment with a focus on diversity.
• Commitment to employee well-being and accommodations for disabilities.