Validation Lead

Roles & Responsibilities

• Plan, coordinate, and lead the execution of validation activities, including qualification and validation of data products and software applications .
• Develop, review, and approve validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports.
• Ensure validation strategies meet regulatory requirements and company standards.
• Write, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents.
• Stay updated on relevant changes to Amgen's SOPs and ensure validation practices are aligned 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.
• Track the progress of validation activities and work closely with the produc...