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Amgen is one of the worldโs leading biotech companies, operating since 1980 and impacting millions of patients through innovative therapies across Oncology, Inflammation, General Medicine, and Rare Diseases. With a strong focus on science and patient-first values, Amgen offers a collaborative, diverse, and growth-oriented work environment.
Roles & Responsibilities
1. Computer System Validation (CSV)
- Support planning, execution, and documentation of validation activities for GxP systems
- Develop validation plans, risk assessments, test scripts & summary reports
- Ensure system changes comply with Amgenโs SDLC and remain in a validated state
2. Testing & Quality Assurance
- Design and execute functional, integration, and regression test cases
- Track and resolve defects; maintain GxP-compliant documentation
- Coordinate and support User Acceptance Testing (UAT)
3. Change & Release Management
- Participate in change control processes
- Assess validation impacts and review change documentation
- Follow Amgenโs IT Quality Management System (QMS)
4. System Support & Readiness
- Maintain lifecycle validation documentation and traceability
- Support periodic reviews, audits, and incident management
- Contribute to process improvement initiatives
Qualifications
Basic Qualifications
- Bachelorโs/Masterโs degree in IS, CS, Engineering, Life Sciences, or related field
- 0โ4 years of relevant experience
Preferred Qualifications
- Understanding of GxP, CSV, SDLC, FDA 21 CFR Part 11, Annex 11, GAMP 5
- Experience with HP ALM, ValGenesis, Jira, ServiceNow
- Strong knowledge of software testing methodologies
- Experience supporting Quality Systems (LIMS, QMS, eQMS) or cloud-based validated systems
- Good documentation, analytical, and communication skills
Good-to-Have
- Knowledge of QC & QA processes in biopharma
- Experience in automated testing or data validation
- Certs: ISTQB, GAMP 5 Practitioner, AWS Cloud Practitioner
Soft Skills
- Strong analytical & problem-solving ability
- Attention to detail
- Collaboration in global teams
- Accountability and learning agility
Benefits at Amgen
- Competitive salary and total rewards
- Inclusive, science-driven culture
- Career development & global exposure
- Work-life balance and wellness programs
- Opportunities to work on cutting-edge biotech systems
How to Apply
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