Sr. Validation Engineer

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 be working closely with Business collaborators, Product Owner, Business Analysts, Developers, and Testers to ensure that Validation strategy and work are produced for IT Systems. This role will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes. The successful candidate will work on a small team and support continuous improvements and automation within the program. This position combines technical expertise, validation experience, and a strong understanding of regulatory requirements.

The role also demonstrates domain and business process expertise to drive ongoing improvements to validation and meets our regulatory and validation procedures. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated and validated.

Roles & Responsibilities:

• Collaborate with System Architects and Product owners to manage Validation strategy and Deliverable for the GxP applications.
• Develop and manage test cases, protocols, and validation documentation within the Veeva VM Testing Vault.
• Implement test scripts to ensure system compliance with regulatory requirements and organizational standards.
• Identify, document, and track defects during the testing process.
• Collaborate with development teams to resolve defects and validate fixes.
• Ensure all testing and validation activities align with GxP, FDA 21 CFR Part 11, and other regulatory standards.
• Maintain comprehensive audit trails and validation documentation to support regulatory inspections.
• Configure and optimize workflows within the VM Testing Vault to streamline test management and approval processes.
• Partner with quality assurance, IT, and business teams to ensure alignment on validation objectives and testing requirements.
• Act as a liaison between technical teams and customers to ensure system requirements are met.
• Provide training to end-users on Veeva VM Testing Vault functionalities and standard processes.
• Offer ongoing support to ensure effective use of the platform.
• Generate reports and dashboards to monitor testing progress, defect trends, and validation status.

What we expect of you

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

Basic Qualifications and Experience:

• Master’s degree with 4 - 6 years of experience in Computer Science, Business, Engineering, IT or related field OR
• Bachelor’s degree with 6 - 8 years of experience in Computer Science, Business, Engineering, IT or related field OR
• Diploma with 10 - 12 years of experience in Computer Science, Business, Engineering, IT or related field.

Functional Skills:

Must-Have Skills:

• Solid understanding of GxP regulations, specifically 21 CFR Part 11.
• Expertise in defining and implementing validation strategies aligned with regulatory requirements.
• Experience in creating and driving validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ)).
• Excellent communication skills and the ability to collaborate with senior leadership with confidence and clarity.
• Familiarity with GxP Validation management tools such as ALM, Veeva Vault Management etc.

Good-to-Have Skills:

• Proficiency in automation tools and validation software (Application Lifecycle Management and/or Veeva Vault Validation Management).
• Experience of DevOps, Continuous Integration and Continuous Delivery methodology.
• Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies.

Professional Certifications:

• SAFe for Teams certification (preferred)
• Veeva VM certification (preferred)

Soft Skills:

• Able to work under minimal supervision.
• Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work.
• Excellent analytical and gap/fit assessment skills.
• Strong verbal and written communication skills.
• Ability to work effectively with global, virtual teams.
• High degree of initiative and self-motivation.
• Ability to manage multiple priorities successfully.
• Team-oriented, with a focus on achieving team goals.
• Strong presentation and public speaking skills.

Shift Information:

• This position operates on the second shift, from 2:00 PM to 10:00 PM IST. Candidates must be willing and able to work during these hours.

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 and make a lasting impact with the Amgen team.

careers.amgen.com

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.