Associate Validation - ARTIST

Overview

Associate Validation role supporting validation activities for data platforms and solutions, ensuring data and analytics products follow required validation processes, documentation and Amgen SOP compliance.

What you'll do

• Execute validation activities, including qualification and validation of data products and software applications.
• Stay updated on relevant changes to Amgen's SOPs and align validation practices with evolving standards.
• Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps, engineering and platform teams, to drive validation activities and meet project deadlines.
• Ensure timely and effective completion of all validation activities in line with project objectives and schedules.
• Ensure proper documentation of validation activities, including deviations, change control and non-conformance management.
• Stay current on new technologies, validation trends and industry best practices to improve validation efficiencies.
• Collaborate and communicate effectively with product teams.

What you'll need

• Bachelor's/Master's degree and 2 to 4 years of experience in Supply Chain Technology, Supply Chain Business, Engineering, IT or related field OR
• Experience in software validation projects.
• Proficiency in executing validation protocols (IQ, OQ, PQ), reports and related documentation.
• Strong problem-solving and analytical skills.
• Excellent communication and teamwork skills.

Nice to have

• Familiarity with computer system validation and software validation.
• Experience with automated and computer-controlled systems validation (21 CFR Part 11).

Details

• Location: Hyderabad, India.
• Ability to work effectively with global, virtual teams.