Description

<h2>Career Category</h2>Information Systems<h2></h2><h2>Job Description</h2><div><div>Join Amgen’s Mission of Serving Patients </div><div>Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. </div><div>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. </div><div>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. </div><div>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. </div><div> </div><div>What you will do </div><div>Let’s do this. Let’s change the world. </div><div>In this critical role, you will serve as the end-to-end Change Owner and Test Manager for the SAP/ERP portfolio, ensuring that all system changes are planned, assessed, tested, validated, and released in compliance with GxP regulations, Amgen IT-QMS, and change and test management processes aligned with global best practices. </div><div>You will be accountable for driving Change controls, risk-based testing strategies, coordinating test execution, managing defects, and ensuring test evidence supports validation and release decisions across Amgen’s SAP landscape. </div><div> </div><div>Roles & Responsibilities: </div><div><ul><li>Act as the single point of accountability for SAP ERP changes across projects, enhancements, fixes, and operational maintenance. </li></ul></div><div><ul><li>Own and execute the change lifecycle including: </li></ul></div><div><ul><li>Change initiation and classification </li></ul></div><div><ul><li>Impact and risk assessment </li></ul></div></div><div><div><ul><li>Approval coordination (Change managers, Business, SMEs, Quality, CAB) </li></ul></div><div><ul><li>Implementation oversight </li></ul></div><div><ul><li>Post-implementation verification and closure </li></ul></div><div><ul><li>Ensure all SAP changes comply with: </li></ul></div><div><ul><li>21 CFR Part 11/ EU Annex 11 regulations </li></ul></div><div><ul><li>ALCOA+ data integrity principles </li></ul></div><div><ul><li>GAMP 5 and CSA (Computer Software Assurance) </li></ul></div><div><ul><li>Serve as the Test Manager for SAP ERP changes, responsible for planning, coordinating, and overseeing test activities. </li></ul></div><div><ul><li>Ensure changes maintain effective controls for: </li></ul></div><div><ul><li>User access and segregation of duties </li></ul></div><div><ul><li>Audit trails and logging </li></ul></div><div><ul><li>Configuration vs. customization decisions </li></ul></div><div><ul><li>Define and implement risk-based test strategies aligned with CSA principles, ensuring appropriate test coverage for: </li></ul></div><div><ul><li>Functional requirements </li></ul></div><div><ul><li>Business processes </li></ul></div><div><ul><li>Compliance and data integrity risks </li></ul></div><div><ul><li>Ensure development, review, and execution of test assets, including: </li></ul></div><div><ul><li>Test strategy and test plans </li></ul></div><div><ul><li>IQ / OQ / PQ or UAT test scripts (as applicable) </li></ul></div><div><ul><li>Traceability between requirements, risks, tests, and defects </li></ul></div></div><div><div><ul><li>Coordinate testing across SAP platforms including ECC, S/4HANA, BTP, GRC, Solution Manager (SolMan), integrations, and boundary systems. </li></ul></div><div><ul><li>Oversee defect management, including: </li></ul></div><div><ul><li>Defect triage and prioritization </li></ul></div><div><ul><li>Root cause analysis in collaboration with SAP teams </li></ul></div><div><ul><li>Verification of defect resolution prior to release </li></ul></div><div><ul><li>Ensure test execution is timely, documented, and audit-ready, supporting release and validation decisions. </li></ul></div><div><ul><li>Partner with Quality and Compliance to: </li></ul></div><div><ul><li>Assess validation impact of changes </li></ul></div><div><ul><li>Define required validation and testing deliverables </li></ul></div><div><ul><li>Ensure traceability between requirements, risks, changes, testing and release </li></ul></div><div><ul><li>Coordinate with SAP developers, functional teams, testers, and SMEs to ensure integrated and compliant delivery. </li></ul></div><div><ul><li>Support release planning, cutover activities, and hypercare as required. </li></ul></div><div><ul><li>Maintain audit-ready documentation and evidence for change, testing, validation, incident, and deviation activities. </li></ul></div><div><ul><li>Support internal and external audits by providing change and test-related evidence and responding to audit inquiries. </li></ul></div><div><ul><li>Identify opportunities to optimize change and test processes, reduce manual effort, and improve cycle time while maintaining quality and compliance. </li></ul></div><div><ul><li>Contribute to digital validation and test automation initiatives, including standardized templates and tooling. </li></ul></div><div><ul><li>Promote consistent adoption of CSA-aligned testing practices across SAP programs and operations. </li></ul></div><div> </div><div>What we expect of you </div><div>We are all different, yet we all use our unique contributions to serve patients. </div></div><div><div>Basic Qualifications and Experience: </div><div><ul><li>Master’s degree and 3+ years of experience in Computer Science, IT, or Life Sciences Change/Test Management with CSV/CSA understanding in a GxP-regulated environment OR </li></ul></div><div><ul><li>Bachelor’s degree and 5+ years of experience in Computer Science, IT, or Life Sciences Change/Test Management with CSV/CSA understanding in a GxP-regulated environment OR </li></ul></div><div><ul><li>Diploma and 8+ years of experience in Computer Science, IT, or Life Sciences Change/Test Management with CSV/CSA understanding in a GxP-regulated environment </li></ul></div><div><ul><li>Hands-on experience supporting SAP ERP systems in a GxP-regulated environment </li></ul></div><div><ul><li>Strong working knowledge of: </li></ul></div><div><ul><li>IT Change and Test Management processes </li></ul></div><div><ul><li>SAP ERP landscapes </li></ul></div><div><ul><li>Validation and compliance processes </li></ul></div><div><ul><li>Regulatory requirements (21 CFR Part 11, Annex 11, ALCOA+, GAMP 5) </li></ul></div><div><ul><li>Experience working within SDLC, Agile, Transport Management, and IT-QMS frameworks </li></ul></div><div>Preferred Qualifications: </div><div><ul><li>Experience supporting SAP transformation initiatives (Ex: ECC to S/4HANA upgrades). </li></ul></div><div><ul><li>Hands-on experience developing and managing test strategies and test execution for SAP systems </li></ul></div><div><ul><li>Experience with CSA-aligned, risk-based testing approaches </li></ul></div><div><ul><li>Experience working with test and ITSM tools (ex: ServiceNow, SolMan, ALM, test management tools) </li></ul></div><div><ul><li>Exposure to audits or inspections supporting SAP systems in a GxP environment. </li></ul></div><div><ul><li>Experience working in global, matrixed teams </li></ul></div><div>Professional Certifications </div><div><ul><li>Scrum Master or equivalent </li></ul></div></div><div><div><ul><li>ITIL / Change Management certification </li></ul></div><div><ul><li>Testing or Quality certification (ISTQB or equivalent - preferred) </li></ul></div><div>Soft Skills: </div><div><ul><li>Strong sense of ownership and accountability </li></ul></div><div><ul><li>Excellent communication and stakeholder-management skills </li></ul></div><div><ul><li>Ability to balance compliance requirements with business agility </li></ul></div><div><ul><li>Structured, detail-oriented, and risk-aware mindset </li></ul></div><div><ul><li>Comfortable working across Global stakeholders (Business, IT, SMEs and Quality & Compliance teams) </li></ul></div><div>What you can expect of us </div><div>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. </div><div>In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. </div><div>EQUAL OPPORTUNITY STATEMENT </div><div>Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. </div><div>We Reasonable accommodation will be provided to individuals with disabilities to participate in the job application or interview process and to perform essential job functions. </div><div>Apply now </div><div>For a career that defies imagination </div><div>Objects in your future are closer than they appear. Join us at careers.amgen.com </div></div>.

ERP/SAP Change Owner and Test Manager

Description

Amgen

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