Join Amgen's Mission of Serving Patients and transform the lives of patients while transforming your career as an Associate Systems Analyst. Responsible for planning and executing software testing, supporting validation deliverables, coordinating system changes, and ensuring adherence to Amgen's Computer System Validation (CSV) policies and procedures.
Requirements
- Bachelors/Masters degree with 0 to 4 years of experience in Information Systems, Computer Science, Engineering, Life Sciences, or a related discipline.
- Foundational understanding of GxP regulations, Computer System Validation (CSV), and Software Development Lifecycle (SDLC) in a regulated environment.
- Experience with validation testing tools (e.g., HP ALM, ValGenesis, Jira) and ITIL-based support processes (e.g., ServiceNow).
- Strong knowledge of testing methodologies and ability to author and execute test cases.
- Understanding of data integrity principles and compliance requirements (FDA 21 CFR Part 11, Annex 11, GAMP 5).
- Experience supporting Quality Systems (e.g., LIMS, QMS, eQMS, data analytics tools) or cloud-based validated applications (e.g., AWS, SaaS).
- Strong analytical skills with attention to detail and documentation quality.
- Excellent written and verbal communication skills to interface effectively with both technical and business stakeholders.
Benefits
- Competitive and comprehensive Total Rewards Plans
- Inclusive environment of diverse, ethical, committed and highly accomplished people
- Opportunities for professional and personal growth and well-being