Specialist IS Business Systems Analyst - Computer Validation SME

About the role

Amgen is hiring a Specialist IS Business Systems Analyst as a subject matter expert in computer system validation (CSV) for its North Carolina Technology team. The role is an individual contributor who helps drive productivity by streamlining, optimizing and automating processes, supports the Computer Systems Compliance team in meeting global regulatory requirements, and reports directly to the ANC Technology Regulatory Compliance Lead, Senior Manager.

Key responsibilities

• Act as SME in CSV, regulatory compliance, data integrity, quality systems and inspection readiness, partnering with the business to keep systems reliable, compliant and efficient.
• Contribute to strategies for CSV, regulatory compliance and sustained inspection readiness, and support inspection readiness activities such as playbooks, guidance, system documentation and readiness tracking tools.
• Provide compliance and validation oversight for digital platform implementations, covering planning, risk identification and regulatory adherence.
• Support digital technology services and collaborate on support models, including coordination with vendors and third-party providers.
• Take part in cross-functional initiatives, meetings and working sessions, and help deliver solutions that improve efficiency and quality.
• Manage multiple priorities, track performance metrics for continuous improvement, and stay current with regulatory expectations and emerging technologies.

Required profile

• Basic qualification: doctorate; or master's degree with 2 years of Information Systems or Engineering experience; or bachelor's degree with 4 years; or associate's degree with 8 years; or high school diploma / GED with 10 years of Information Systems or Engineering experience.
• Preferred: prior experience in biotechnology, pharmaceutical or other regulated industries, and hands-on experience in computer validation, regulatory compliance and inspection readiness.
• Strong problem-solving, communication, decision-making, adaptive leadership and organizational skills.

What we offer

• Annual salary range posted for the U.S. (excluding Puerto Rico), varying with skills, experience and qualifications.
• Total rewards including health, dental and vision coverage, life and disability insurance, retirement savings plan with company contributions, and a flexible spending account.
• Discretionary annual bonus or sales-based incentive plan, stock-based long-term incentives, and time-off plans.
• Flexible work models where possible.