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Specialist IS Engineer

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Amgen

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Location:
United States , Thousand Oaks

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Category:
IT - Software Development

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Contract Type:
Employment contract

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Salary:

138674.00 - 144146.00 USD / Year
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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.

Job Responsibility:

  • 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)
  • May telecommute

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
What we offer:
  • 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
  • discretionary annual bonus program
  • stock-based long-term incentives
  • award-winning time-off plans
  • flexible work models, including remote and hybrid work arrangements

Additional Information:

Job Posted:
May 05, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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