Job Description

Career Category

Project Management

Join Amgen’s Mission of Serving Patients

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier,fullerand longer. We discover, develop,manufactureand deliver innovative medicines to help millions of patients. Amgen helpedestablishthe biotechnology industry more than 40 years ago andremainson thecutting-edgeof innovation, using technology and human genetic data to push beyondwhat’sknown today.

At Amgen, if you feel likeyou’repart of something bigger,it’sbecause you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980,we’vehelped 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’llhelp 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 thatlaywithin them,you’llthrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

What youwill do

Let’sdo this.Let’schange the world.

In this critical role, you will serve as the end-to-end Change Owner for SAPERPportfolio, ensuring that all system changes are planned, assessed, implemented,validated, and released in compliance withGxPregulations, Amgen IT-QMSand change management processaligned toglobalbest practices

You will partner closely with Business, ERPproductdelivery teams, Validation, and Quality to enable risk-based, audit-ready, and efficient change execution across Amgen’s SAP landscape.

Roles & Responsibilities:

• Act as the single point of accountability for SAP ERP changes across projects, enhancements, fixes, and operational maintenance.

• Own and execute the change lifecycle including:

• Change initiation and classification

• Impact and risk assessment

• Approval coordination (Change managers,Business,SMEs,Quality, CAB)

• Implementation oversight

• Post-implementation verification and closure

• Ensure all SAP changescomply with

• 21 CFR Part 11EU Annex 11regulations

• ALCOA+ data integrity principles

• GAMP 5 and CSA (Computer Software Assurance)

• Partner withQuality and Complianceto:

• Assess validation impact of changes

• Assessrequired validation deliverables

• Ensure traceability between requirements, risks, testing, and release

• Support SAP platforms including ECC, S/4HANA, BTP, GRC, SolutionManager(Solman), integrations, and boundary systems.

• Ensure changesmaintaineffective controls for:

• User access and segregation of duties

• Audit trails and logging

• Configuration vs. customization decisions

• Coordinate with SAPdevelopment,functional, testers andSME’sto ensuretimelyand compliantdeploymentof changes.

• Support release planning, cutover activities, andhypercareasrequired

• Maintain audit-ready documentation and evidence for change, validation, incident, and deviation activities.

• Proactivelyidentifyopportunities to simplifyandoptimizechange processes, reduce rework, and improve cycle time whilemaintainingquality andcompliance.

• Contribute to continuous improvement initiativesacross the Change management, including adoption of digital validation, automation, and standardized templates.

• Support internal and external audits by providing change-related evidence and responding to audit inquiries

What we expectofyou

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications and Experience:

• Master’s degree and3+years of Computer Science, ITLifesciences Change Management withComputerized systems Validation/Assurance(CSV/CSA)understandingin aGxPregulated environment OR

• Bachelor’s degree and5+years of Computer Science,TLifesciences Change Management withComputerized systems Validation/Assuranceunderstandingin aGxPregulated environment OR

• Diploma and8+years of Computer Science,ITLifesciences Change Management withComputerizedsystemsValidation/Assuranceunderstanding in aGxPregulated environment

• Hands-on experience supporting SAP ERP systems in aGxP-regulated environment

• Strong working knowledge of:

• IT Change Management

• Strong understanding of SAP ERP landscapes

• Validation and compliance processes

• Regulatory requirements (21 CFR Part 11, Annex 11, ALCOA+, GAMP 5)

• Experience working within structured SDLC, Agile, Transport Managementand IT-QMS frameworks.

Preferred Qualifications:

• Experience supporting SAP transformation initiatives (Ex:R/3 to ECC and/or ECCtoS/4HANA upgrades).

• Familiarity with CSA-aligned, risk-based validation approachesandHandson experience preparing change and validation documentation

• Experience working with ITSM and change management tools (Ex, ServiceNow, Solman).

• Exposure to audits or inspections supporting SAP systems.

• Experience working in global, matrixed teams.

Professional Certifications

• Scrum Masteror equivalent

• ITIL / Change Management certification

Soft Skills:

• Strongsense of ownership and accountability

• Excellent communication and stakeholder-management skills

• Ability to balance compliance requirements with business agility

• Structured, detail-oriented, and risk-aware mindset

• Comfortable working across Business, IT, and Quality teams

What you can expectofus

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’llsupport 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.

EQUAL OPPORTUNITY STATEMENT

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.

We Reasonable accommodation will be provided to individuals with disabilities toparticipatein the job application or interview process and to perform essential job functions.

Apply now

For a career that defies imagination

Objects in your future are closer than they appear. Join usat careers.amgen.com