Roles & Responsibilities Plan, coordinate, and execute validation activities, including qualification and validation of data products and software applications. Develop validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports and get them reviewed and approved. Ensure validation strategies meet regulatory requirements and company standards. Write Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation (CSV) documents and coordinate for approvals. Stay updated on changes to Amgen's SOPs and ensure validation practices align with evolving standards. Collaborate with cross-functional teams (QA, system owners, business owners, RunOps, engineering, and data teams) to drive validation activities. Track progress of validation deliverables and coordinate timelines with product owners and scrum masters to align with project schedules. Ensure timely and effective execution of all validation tasks in accordance with project goals. Maintain complete and compliant documentation of validation activities, including deviations, change controls, and non-conformances. Identify opportunities for process improvements in validation activities. Stay current on technologies, validation trends, and industry best practices to improve efficiency. Communicate and collaborate effectively with product teams. Basic Qualifications and Experience Master's degree with 1 - 3 years of experience in Business, Engineering, IT, or related field Bachelor's degree with 2 - 5 years of experience in Business, Engineering, IT, or related field Diploma with 6 - 8 years of experience in Business, Engineering, IT, or related field Functional Skills Must-Have Skills 2+ years of experience in validation within a GxP-regulated environment (pharma, biotech, medical devices, etc.) Experience working in software validation projects Strong experience using tools like ALM and JIRA Prior experience working in Agile or SAFe environments Experience with automated and computer-controlled systems validation (e.g., 21 CFR Part 11 ) Ability to write and execute validation scripts independently in ALM Experience with computer system and software validation Strong problem-solving and analytical skills Excellent communication and teamwork abilities Good-to-Have Skills Understanding of compliance and regulatory considerations in Master Data Management (MDM) In-depth knowledge of GDPR and HIPAA guidelines Prior work experience in the MDM domain Hands-on experience with Confluence in addition to JIRA Professional Certifications CSV Certified Agile or SAFe certified Soft Skills Strong analytical abilities to assess and enhance master data processes Excellent verbal and written communication skills for both technical and non-technical stakeholders Effective problem-solving to address validation/data-related issues Ability to work independently and collaboratively with global, virtual teams