Specialist IS Engineer

Career Category
Information Systems
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.

Specialist IS Engineer

What you will do and what we expect of you

Let's do this. Let's change the world. In this vital role you will:

Duties: Evaluate Veeva features, determine their potential value, and present a demonstration to the Business Governance members; Design, prototype, document, build, configure, test, and implement CDOCS (ControlledDocs - A Veeva Vault Quality Document Management System) configurations to support business requirements and User Stories; Create and execute validation test scripts in ALM (Application Life Cycle Management) Tool; Perform Installation Qualification and Qualification Testing protocols; Ensure that the solution aligns with Amgen IS strategy, standards, and operating procedures to maintain the system in a validated state; Lead and run all aspects of deviation and non-conformance incidents for CDOCS including performing the root cause investigation, identification of corrective and preventative actions (CAPA), performing effectiveness verifications (EV), and thoroughly documenting the findings and results; Lead complex IS document migration projects into CDOCS, particularly those resulting from Merger and Acquisition activities; Support in Analysis, Design, Test, Implementation, change management phases of various ongoing projects; and Plan and lead product improvement releases using Agile methodology (Scrum master). May telecommute.

Requirements: Master's degree (or foreign equivalent) in Computer Science, Information Technology, or related field & 3 years of experience involving the following:

1. Performing and maintaining computerized system validation per FDA 21 CFR part 11 guidance for GXP systems, including identifying and implementing opportunities for continuous improvement related to compliance practices and issues based on internal compliance;

2. Biotech industry and working with GxP computer systems in a regulated environment;

3. Working with business clients to understand business processes, lead scope of work, expectations and suggest, and recommend solutions;

4. IS change control process and building, validating, and supporting GxP systems;

5. Planning, executing and documenting the validation activities in compliance with Computer System Validation (CSV);

6. Define automation testing strategy with an inhouse automation framework; and

7. Conduct user acceptance testing sessions and ensure the system is built per business needs.

Contact: Interested candidates please apply via and search for job # R-239020.

Job type: Full Time position. The annual salary range for this position in the U.S. is $138,674.00 - $144,146.00 per year. Also, this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation. For more details visit

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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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.

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