SAP Validation Functional Analyst

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 implement the qualification and validation processes for the Enterprise Resource Planning (ERP) solutions and platform. This role is an expert in implementing validation plans and agile methodologies, ensuring compliance of the delivery teams with industry standards and regulatory requirements in a Life Sciences environment.

Roles & Responsibilities:

• Lead all aspects of the qualification and validation deliverables of SAP ERP systems to ensure they meet industry standards and regulatory requirements.

• Create and implement detailed validation plans for SAP implementations, aligning with project timelines and deliverables.

• Collaborate with ERP projects and product teams, Quality Assurance, and business collaborators to define validation requirements, ensuring comprehensive testing and compliance.

• Develop and maintain critical validation documentation, including IQ, OQ, test scripts, and traceability matrices.

• Know the latest with GxP regulations, ensuring ongoing compliance and readiness for audits.

What we expect of you

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

Basic Qualifications:

• Master’s degree and 1 to 3 years of Computer Science, IT or related field experience OR

• Bachelor’s degree and 3 to 5 years of Computer Science, IT or related field experience OR

• Diploma and 7 to 9 years of Computer Science, IT or related field experience

• Extensive SAP Validation Experience: Minimum of 2 years in validating SAP systems in a regulated environment.

• Documentation Proficiency: Expertise in creating and managing validation documentation, including IQ, OQ, and test scripts.

• Regulatory Compliance Knowledge: In-depth understanding of GxP regulations.

Preferred Qualifications:

• Experience with Agile / Scaled Agile Framework (SAFe) methodologies for software delivery.

• Experience with validations tools such as CDOCs, ALM and JIRA.

Professional Certifications

• Scrum Master (preferred)

• SAP certification (preferred)

Soft Skills:

• Strong capability to analyze complex issues and develop effective solutions.

• Excellent verbal and written communication skills for collaborator interactions and documentation.

• High degree of precision in managing validation documentation and ensuring regulatory compliance.

• Ability to manage changing requirements and priorities effectively.

• Ability to focus on team collaboration and achieving project goals.

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

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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