PLM Software Quality & Validation Engineer - Remote

Overview

In this vital role, you will collaborate closely with cross-functional teams to ensure that the PLM solutions follow the required validation processes, documentation, and align with Amgen’s standard operating procedures, policies, and guidelines.

In Short

• Collaborate with cross-functional teams to ensure quality and compliance.
• Involve in various types of testing such as Functional, System, Stress, and Performance.
• Develop and maintain comprehensive test plans for 3DExperience platform modules.
• Ensure validation strategies meet regulatory requirements.
• Assist with UAT, test data preparation, and developing work instructions.
• Contribute to test automation scripting and CI/CD integration.
• Document validation activities and manage deviations and non-conformance.
• Collaborate with multi-functional teams to drive validation activities.
• Stay updated on validation trends and industry standards.
• Implement process improvements in validation activities.

Requirements

• Master's or Bachelor's degree with 5 to 9 years of experience in Software Quality and GMP Validation.
• Experience in QA testing on the 3DEXPERIENCE platform or similar PLM solutions.
• Experience in validation in a GMP-regulated environment.
• Proficiency in developing and executing validation protocols.
• Strong problem-solving and analytical skills.
• Excellent verbal and written communication skills.
• Ability to work effectively with global teams.
• Strong initiative and self-motivation.
• Ability to manage multiple priorities successfully.
• Team-oriented with a focus on achieving goals.

Benefits

• Competitive salary and comprehensive Total Rewards Plans.
• Support for professional and personal growth.
• Collaborative culture.
• Opportunities for process improvements and innovation.
• Work in a leading biotechnology company.