Sr Validation Engineer

Career Category

Job Description

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 support the implementation and operational management of real-world evidence platforms at Amgen, ensuring the integrity and compliance of critical systems and data. This role involves collaboration with various Amgen teams to enhance and secure real-world evidence operations.

This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will collaborate with Product Managers and developers to maintain an efficient and consistent process, ensuring quality results from the team.

Roles & Responsibilities:

• Develop detailed test plans and strategies based on project requirements and specifications.
• Perform manual and automated testing of software applications, including functional, regression, and performance testing.
• Document and report defects and issues identified during testing, and work with development teams to resolve them.
• Maintain detailed documentation of test/validation plans, test cases, and test results.
• Validate that test scenarios meet feature acceptance criteria and customer expectations.
• Maintain and ensure the quality of documented user stories/requirements in tools such as Jira.
• Provide experienced technical support in validation to meet objectives of quality, output and cost in developing, trouble shooting, standardizing and improving new and existing equipment.
• Prepare, execute, document, and report validation protocols in line with GxP’s and other regulatory requirements and standards.
• Assure that all validation test procedures are in line with current technology, corporate, and governmental regulations.
• Perform IQ, OQ, and PQ validation on processes, equipment, and systems in conjunction with suppliers as appropriate.

What we expect of you

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

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

Functional Skills:

Must-Have Skills:

• Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology
• Experience with Agile software development methodologies (Scrum)
• Excellent communication skills and the ability to interface with senior leadership with confidence and clarity
• Experience with validation solutions, including compliance and data integrity.

Good-to-Have Skills:

• Familiarity with cloud platforms (AWS / Databricks) and GCP regulations.
• Experience with validation solutions, including compliance and data integrity.
• Able to communicate technical or complex subject matters in business terms
• Jira Align experience

Professional Certifications:

• SAFe for Teams certification (preferred)

Soft Skills:

• Able to work under minimal supervision.
• 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 manage multiple priorities successfully.
• Team-oriented, with a focus on achieving team goals.
• Strong presentation and public speaking skills.

Shift Information:

This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.

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.