Specialist IS Business Systems Analyst
Amgen · Holly Springs, NC
IT & SoftwareFull-timeCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Amgen seeks a specialist business systems analyst to serve as a subject matter expert in computer system validation, regulatory compliance, and data integrity for the Technology organization in North Carolina. The role involves partnering with cross-functional teams to ensure adherence to global quality standards, support inspection readiness, and optimize compliant digital platform implementations.
What they're looking for
- Doctorate degree, or Master's degree with 2+ years IS/Engineering experience
- Deep knowledge of computer system validation, regulatory compliance, and inspection readiness
- Prior experience in biotechnology, pharmaceutical, or regulated industries strongly preferred
- Strong verbal, written, and presentation skills for stakeholder engagement
- Critical thinking and problem-solving ability to design scalable solutions
- Experience with computerized systems lifecycle and data integrity practices
What you'll be doing
- Serve as SME in computer system validation, regulatory compliance, and data integrity for Technology organization
- Partner with business teams to identify process bottlenecks and optimization opportunities while maintaining compliance
- Support inspection readiness activities including playbook development, documentation, and readiness tracking
- Provide validation and compliance oversight for digital platform implementations and system deployments
- Collaborate with cross-functional teams to develop strategies supporting CSV and sustained inspection readiness
Privacy & handoff
This role links to Amgen's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.