Specialist IS Business Systems Analyst

Career Category

Information Systems

Specialist IS Business Systems Analyst – Technology Computer Validation SME

In this vital role, you will join the Amgen North Carolina Technology team as an individual contributor, helping to drive productivity by identifying opportunities to streamline, optimize, and automate processes where appropriate. You will support the Computer Systems Compliance team by ensuring adherence to global regulatory requirements and Amgen procedures.

Acting as a subject matter expert (SME) in computer system validation (CSV), regulatory compliance, data integrity, quality systems and inspection readiness, you will partner with the business to maintain reliable, compliant and efficient systems.

You will proactively promote a culture of quality and continuous compliance, ensuring alignment with global quality standards and sustaining a constant state of inspection readiness. This position reports directly to the ANC Technology Regulatory Compliance Lead, Senior Manager.

• Serve as a subject matter expert (SME) in computer system validation (CSV), regulatory compliance, data integrity, quality systems, and inspection readiness for the Technology organization.
• Contribute to the development and execution of strategies supporting CSV, regulatory compliance, and sustained inspection readiness.
• Partner with cross-functional teams to ensure alignment with global quality and compliance standards and practices.
• Support inspection readiness activities, including development of playbooks, SME guidance, system documentation, and readiness tracking tools.
• Provide compliance and validation oversight for digital platform implementations, ensuring appropriate planning, risk identification, and adherence to regulatory expectations.
• Support digital technology services by ensuring validation, compliance, data integrity, and system reliability requirements are met.
• Collaborate in the design and implementation of support models, including coordination with vendors and third-party providers.
• Participate in cross-functional initiatives, contributing expertise in meetings and providing updates to stakeholders as needed.
• Help deliver solutions that enhance efficiency, quality, and alignment with business objectives.
• Manage multiple priorities and contribute to resolving complex compliance and validation challenges.
• Support the development and tracking of performance metrics to enable continuous improvement.
• Contribute to successful project execution and promote operational excellence.
• Stay current with industry trends, regulatory expectations, and emerging technologies to inform best practices.

• Partner with business teams to understand processes, identify bottlenecks, and uncover opportunities to improve efficiency while maintaining compliance.
• Collaborate with system owners and business stakeholders to evaluate and recommend quality-compliant system solutions and computer validation strategies.
• Contribute to the Computerized Systems Lifecycle, including gathering requirements, supporting process and system analysis, and helping define integration and design approaches.
• Participate in cross-functional meetings and working sessions to support system optimization and implementation of automated, compliant solutions.
• Champion data integrity by ensuring computerized systems meet compliance standards and support overall quality objectives.

We are all different, yet we all use our unique contributions to serve patients. The technology professional we seek is a team player with these qualifications.

Doctorate degree

OR

Master’s degree and 2 years of Information Systems or Engineering experience

OR

Bachelor’s degree and 4 years of Information Systems or Engineering experience

OR

Associate’s degree and 8 years of Information Systems or Engineering experience

OR

High school diploma / GED and 10 years Information Systems or Engineering experience

• Industry experience preferred:
  Prior experience in biotechnology, pharmaceutical, or related regulated industries is strongly preferred.
• Depth knowledge and hand on experience in computer…