Specialist IS Business Systems Analyst – Technology Computer Validation SME

What you will do

Let’s do this. Let’s change the world. 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.

What we expect of you

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.

Basic 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

Preferred Qualifications:

• Industry experience preferred: 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.
• Drive problem solving and innovation: Apply critical thinking and best practices to proactively resolve complex issues and design effective, scalable solutions.
• Communicate with clarity: Demonstrate strong verbal, written, and presentation skills to engage stakeholders, senior management, and lead teams effectively.
• Decision-making: Clearly articulates the rationale behind decisions and their potential implications, continuously reflecting on successes and failures to enhance performance and decision-making.
• Adaptive leadership: Recognizes the need for change and actively participates in technical strategy planning.
• Balance priorities: Manage multiple initiatives with strong organizational skills, ensuring alignment with team goals and measurable performance outcomes.

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• 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. Refer to the Work Location Type in the job posting to see if this applies

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

.

Salary Range