SAP Validation Functional Analyst
SAP Validation Functional Analyst
India - Hyderabad APLICAR AHORAJoin 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.
SAP Validation Functional Analyst
What you will do
Let’s do this. Let’s change the world. In this vital role, you will support the qualification, validation, and compliance processes for SAP ERP solutions and related platforms. You will work closely with senior team members, Quality, and business partners to ensure validation deliverables are executed to meet industry standards and regulatory requirements in a Life Sciences environment.
Roles & Responsibilities:
- Execute validation deliverables for SAP ERP systems (ECC, S/4HANA, BTP, GRC, and related platforms) in alignment with Amgen’s procedures and regulatory expectations.
- Support the creation, execution, and review of validation documentation (e.g., Validation Plan, Requirements, IQ, OQ, PQ/UAT test scripts, Traceability Matrix, Validation Report).
- Collaborate with project teams, quality assurance, and business stakeholders to ensure requirements are clearly defined and properly tested.
- Assist in maintaining operational compliance for SAP systems, including activities related to Incident Management, Problem Management, Change Control, CAPA, and Deviation tracking.
- Participate in periodic reviews, user access reviews (UARs), and audit trail checks to maintain ongoing compliance.
- Contribute to audit readiness by supporting evidence collection and responding to inspection requests.
- Stay current with evolving GxP regulations, guidelines (21 CFR Part 11, Annex 11, GAMP 5), and Amgen’s IT-QMS.
- Explore opportunities to leverage digital validation and automation tools to improve efficiency.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients.
Basic Qualifications and Experience:
- Any degree and 5-9 years of Computer Science, IT or related field experience OR
- Extensive SAP Validation Experience: Minimum of 2 years in validating SAP systems in a regulated environment.
- Documentation Proficiency: Expertise in creating and managing Risk based validation documentation including Validation Plan, Specifications, IQ, OQ, PQ/UAT, RTM and Validation Report.
- Regulatory Compliance Knowledge: In-depth understanding of GxP regulations.
Preferred Qualifications:
- Experience with validation or ITSM tools (e.g., ServiceNow, Veeva CDOCs, ALM, JIRA)
- Exposure to Agile or SAFe methodologies for IT delivery
- Good to have SAP or quality-related certifications
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.