Specialist IS Business Systems Analyst
Amgen Inc
Amgen Specialist Is Business Systems Analyst – Technology Computer Validation SmeJoin Amgen's Mission of Serving PatientsAt 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.What You Will DoLet'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.A Day In LifePartner 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 YouWe 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 degreeORMaster's degree and 2 years of Information Systems or Engineering experienceORBachelor's degree and 4 years of Information Systems or Engineering experienceORAssociate's degree and 8 years of Information Systems or Engineering experienceORHigh school diploma / GED and 10 years Information Systems or Engineering experiencePreferred 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 UsAs 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 accountsA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible work models where possible. Refer to the Work Location Type in the job posting to see if this appliesApply now and make a lasting impact with the Amgen team.
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