Specialist IS Engineer

Amgen•Thousand Oaks, CA

1d•Remote

About The Position

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:

Requirements

Master’s degree (or foreign equivalent) in Computer Science, Information Technology, or related field & 3 years of experience involving the following:
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
Biotech industry and working with GxP computer systems in a regulated environment
Working with business clients to understand business processes, lead scope of work, expectations and suggest, and recommend solutions
IS change control process and building, validating, and supporting GxP systems
Planning, executing and documenting the validation activities in compliance with Computer System Validation (CSV)
Define automation testing strategy with an inhouse automation framework
Conduct user acceptance testing sessions and ensure the system is built per business needs

Nice To Haves

May telecommute.

Responsibilities

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
Plan and lead product improvement releases using Agile methodology (Scrum master)

Benefits

stock
retirement
medical
life and disability insurance
eligibility for an annual bonus
Retirement and Savings Plan with generous company contributions
group medical, dental and vision coverage
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