Specialist IS Business Systems Analyst

Amgen • Holly Springs, NC

1d

About The Position

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Specialist IS Business Systems Analyst – Technology Computer Validation SME. In this vital role, you will join the Amgen North Carolina (ANC) 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. A day in life: 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.

Requirements

• 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

Nice To Haves

• Prior experience in biotechnology, pharmaceutical, or related regulated industries is strongly preferred.
• Depth knowledge and hand on experience in computer validation, regulatory compliance, inspection readiness.
• Apply critical thinking and best practices to proactively resolve complex issues and design effective, scalable solutions.
• Demonstrate strong verbal, written, and presentation skills to engage stakeholders, senior management, and lead teams effectively.
• Clearly articulates the rationale behind decisions and their potential implications, continuously reflecting on successes and failures to enhance performance and decision-making.
• Recognizes the need for change and actively participates in technical strategy planning.
• Manage multiple initiatives with strong organizational skills, ensuring alignment with team goals and measurable performance outcomes.

Responsibilities

• 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.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed