Career Category
Information Systems
Job Description
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. 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 do
Let’s do this. Let’s change the world. In this vital role you will be responsible for planning and executing software testing, supporting validation deliverables, coordinating system changes, and ensuring adherence to Amgen’s Computer System Validation (CSV) policies and procedures in alignment with global regulatory requirements (e.g., FDA 21 CFR Part 11, Annex 11, GAMP 5).
Roles & Responsibilities:
Computer System Validation
- Support the planning, execution, and documentation of validation activities for GxP and quality systems.
- Develop and maintain validation deliverables such as validation plans, risk assessments, test scripts, and summary reports.
- Ensure system changes follow Amgen’s SDLC and remain in a validated state.
Testing & Quality Assurance
- Design and execute test cases (functional, integration, regression) to verify software functionality and data integrity.
- Track and resolve testing defects and document testing evidence in compliance with GxP standards
- Support User Acceptance Testing (UAT) coordination and execution with business stakeholders.
- Change & Release Management
- Participate in change control processes, ensuring that validation impacts are properly assessed and documented.
- Review and approve change documentation aligned with Amgen’s IT Quality Management System (QMS).
System Support & Readiness
- Maintain validation documentation throughout the system lifecycle, ensuring traceability and audit readiness.
- Support periodic reviews, incident resolution, and audit preparations.
- Contribute to process improvement initiatives that enhance validation efficiency and system compliance.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients.
Basic Qualifications:
- Bachelors/Masters degree with 0 to 4 years of experience in Information Systems, Computer Science, Engineering, Life Sciences, or a related discipline.
Preferred Qualifications
- Foundational understanding of GxP regulations, Computer System Validation (CSV), and Software Development Lifecycle (SDLC) in a regulated environment.
- Experience with validation testing tools (e.g., HP ALM, ValGenesis, Jira) and ITIL-based support processes (e.g., ServiceNow).
- Strong knowledge of testing methodologies and ability to author and execute test cases.
- Understanding of data integrity principles and compliance requirements (FDA 21 CFR Part 11, Annex 11, GAMP 5).
- Experience supporting Quality Systems (e.g., LIMS, QMS, eQMS, data analytics tools) or cloud-based validated applications (e.g., AWS, SaaS).
- Strong analytical skills with attention to detail and documentation quality.
- Excellent written and verbal communication skills to interface effectively with both technical and business stakeholders.
Good-to-Have Skills
- Knowledge of Quality Control (QC) and Quality Assurance (QA) processes within the biopharmaceutical industry.
- Familiarity with automated testing, data validation, or data migration verification techniques.
- Certifications such as ISTQB, GAMP 5 Practitioner, or AWS Cloud Practitioner are advantageous.
Soft Skills
- Strong analytical and problem-solving abilities.
- Excellent attention to detail and organizational skills.
- Ability to work collaboratively in global, cross-functional teams.
- High degree of initiative, accountability, and learning agility.
What you can expect of 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.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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