Sr Associate IS 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.

Sr Associate IS Engineer

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for the testing activities for software applications and solutions that meet business needs and ensuring the availability of critical systems and applications. This role is for a Quality assurance tester and validation analyst for the Clinical Data Management and Interactive Response Technology (CDMIRT) product team. The role involves working closely with product managers, designers, and other engineers to test high-quality, scalable software solutions.

Roles & Responsibilities:

• Build test scripts per implementation project plan by working with various members of the product team and business partners.

• Conduct informal and formal testing, consolidate all the findings and coordinate with developer(s) and business partners to resolve all the issues

• Perform regression testing to verify the changes do not negatively impact existing system functionality

• Communicate potential risks and contingency plans with project management to ensure process compliance with all regulatory and Amgen procedural requirements

• Identify and resolve technical challenges/bugs effectively

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

• Support the creating and implementation of automated testing frameworks to improve efficiency and consistency

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 Computer Science/Information Systems experience with Agile Software Development methodologies OR

• Bachelor’s degree with 5-8 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies OR

• Diploma with 10 - 12 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies

Must-Have Skills:

• Knowledge of clinical trial processes specifically software validation processes

• Experience with testing methodologies and automation practices

• Experience with testing tools such as HP Application Lifecycle Management (ALM) and Veeva vault validation management

• Experience in conducting testing activities in GxP systems

• Good Problem-solving skills - Identifying and fixing bugs, adapting to changes

• Excellent communication skills - Explaining design decisions, collaborating with teams

• Experienced in Agile methodology

Good-to-Have Skills:

• Experience in Risk-based Approach to Change Management of Validated GxP Systems

• Working knowledge of SQL scripting

• Experience in RBM/RBQM systems

• Experience with cloud-based technologies

Professional Certifications (please mention if the certification is preferred or mandatory for the role):

• SAFE for Teams certification (Preferred)

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 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.

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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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.