Validation Engineer 1

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

Role Description:

We are seeking a highly skilled Validation Engineer to join our team. You will be responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role involves working closely with product managers, designers, and other engineers to create high-quality, scalable software solutions and automating operations, monitoring system health, and responding to incidents to minimize downtime.

Roles & Responsibilities:

• Develop and maintain Validation Plans, including scope, responsibilities, deliverables, and timelines.

• Perform risk-based assessments to determine the level of validation required.

• Assist in defining User Requirements and Functional Requirements.

• Draft and review various validation artifacts.

• Ensure all documents are compliant with 21 CFR Part 11, Annex 11, and other relevant regulations.

• Coordinate and/or execute validation protocols.

• Support change management processes for validated systems.

• Ensure continuous validation throughout the system lifecycle (including periodic reviews).

• Work closely with cross-functional teams, including product management, design, and QA, to deliver high-quality software on time.

• Stay updated with the latest trends and technologies, and related fields.

• Provide ongoing support and maintenance for applications, ensuring that they operate smoothly and efficiently.

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 experience in Computer Science, IT or related field experience OR

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

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

Must-Have Skills:

• Strong technical background, including understanding software development processes, databases, and cloud-based systems.

• Experience implementing CSA guidance.

• Experience with product backlog management (e.g., Jira) and collaboration tools.

Preferred Qualifications:

• Basic understanding of Veeva Quality Vault.

• Strong Analysis skills with basic Veeva configuration knowledge.

• Excellent communication skills, with the ability to convey complex technical concepts.

Soft Skills:

• Excellent analytical and problem-solving 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.

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.

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 will ensure that individuals with disabilities are provided with 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 an accommodation.

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.