Software Quality & Validation Lead

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.

Software Quality & Validation Lead

What you will do

Let’s do this. Let’s change the world. In this vital role you will be a skilled Software quality & Validation lead to oversee and handle validation activities for data platforms and custom-built solutions. As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data and analytics products follow the required validation processes, documentation, and align with Amgen’s standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant. This is a hands-on, growth-oriented position ideal for someone looking to deepen their skills in Front-end testing, Back-end testing, API testing, and test automation.

You will play a key validation role in a regulatory submission content automation initiative which will modernize and digitize the regulatory submission process, positioning Amgen as a leader in regulatory innovation. The initiative leverages state-of-the-art technologies, including Generative AI, content management, and integrated data to automate the creation, and management of regulatory content.

Roles & Responsibilities:

• Plan, coordinate, and lead the execution of validation activities, including qualification and validation of data products and software applications.

• Develop, review, and approve validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports.

• Ensure validation strategies meet regulatory requirements and company standards.

• Write, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents.

• Stay updated on relevant changes to Amgen’s SOPs and ensure validation practices are aligned with evolving standards.

• Contribute to test automation scripting, framework maintenance, and CI/CD integration.

• Implement automated test suites across various layers including data pipelines, APIs, and semantic layers.

• Analyze test automation results, identify failures or inconsistencies, and assist in root cause analysis.

• Collaborate with multi-functional teams, including quality assurance, system owners, business owners, RunOps, engineering, and platform teams to drive validation activities and meet project deadlines.

• Supervise the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan.

• Ensure timely and effective completion of all validation activities in line with project objectives and schedules.

• Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management.

• Find opportunities for process improvements in validation activities.

• Stay ahead of on new technologies, validation trends, and industry best practices to improve validation efficiencies.

• Collaborate and communicate effectively with the product teams.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

• Master’s degree with 4-6 years of experience in Life Science/Biotechnology/Pharmacology/Information Systems experience OR

• Bachelor’s degree with 6 - 8 years of experience in Life Science/Biotechnology/Pharmacology/Information Systems experience OR

• Diploma with 10 - 12 years of experience in Life Science/Biotechnology/Pharmacology/Information Systems experience

Preferred Qualifications:

Must-Have Skills:

• 5+ years of experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.).

• 8-10 Years overall experience in Testing & Validation Projects

• 3 to 5 years overall experience in QA & Test Automation is expected.

• Experience leading software validation projects.

• Proficiency in developing and implementing validation protocols (IQ, OQ, PQ), reports, and related documentation.

• Hands-on experience implementing and analyzing automated test suites

• Familiarity with computer system validation and software validation is a plus.

• Strong problem-solving and analytical skills.

• Excellent communication and teamwork skills.

Good-to-Have Skills:

• Experience with automated and computer-controlled systems validation (21 CFR Part 11)

Soft Skills:

• Excellent analytical and troubleshooting skills.

• Strong verbal and written communication skills

• Ability to work effectively with global, virtual teams

• High degree of initiative and self-motivation.

• Ability to handle multiple priorities successfully.

• Team-oriented, with a focus on achieving team goals.

• Ability to learn quickly, be organized and detail oriented.

• 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.

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.