
Posted 24 days ago
Sr. Associate Systems Analyst
AmgenSr. Associate Systems Analyst – Clinical Study Design and Analysis
Requirements
Master's degree or Bachelor's degree with 5-9 years experience, GxP-regulated computer system validation experience, Agile software development methodologies (Scrum), Validation solutions and methodologies, Ability to work evening shifts
Skills
AgileScrumJira
About the role
Responsibilities
- Support, monitor, and execute the installation of infrastructure security patches and configuration changes
- Review system release notes to identify and develop detailed regression test requirements and strategies
- Perform manual and automated testing, including functional, regression, and performance testing
- Document and report defects, working closely with development teams to ensure resolution
- Maintain detailed documentation of test/validation plans, test cases, and results in tools like Jira
- Prepare, execute, and report validation protocols (IQ, OQ, PQ) in compliance with GxP and regulatory standards
- Collaborate with business partners and SaaS suppliers to ensure system updates do not negatively impact business processes
Requirements
- Master's degree or Bachelor's degree with 5-9 years of experience in Information Systems Administration, Support, or Validation
- Proven experience with GxP-regulated computer system validation
- Experience working with Agile software development methodologies (Scrum)
- Hands-on experience with validation solutions, tools, and methodologies
- Ability to work evening shifts (second or third shift schedules)
- Strong verbal and written communication skills with the ability to work effectively in global, virtual teams
Preferred Qualifications
- Certified Tester, Agile Tester, or similar professional certification
- Scaled Agile Framework (SAFe) certification
- Experience drafting documentation in adherence to standard operating procedures
- Understanding of biostatistical analysis methods
- Experience with generative AI, agentic AI, and other emerging technologies
About the Company
Amgen is a leading biotechnology company that harnesses the best of biology and technology to fight the world’s toughest diseases. For over 40 years, Amgen has been at the cutting edge of innovation, discovering and delivering innovative medicines to help millions of patients improve their health outcomes.
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Amgen · Hyderabad
