Specialist IS Engineer

Amgen
Thousand Oaks, CA
Category Engineering
Remote
Job Description
Join Amgen's Mission of Serving Patients. Amgen is a biotech company that helps pioneer the world of biotech in its fight against the world's toughest diseases. The company is looking for a Specialist IS Engineer to evaluate Veeva features, design and implement CDOCS configurations, and perform validation testing protocols.

Requirements

  • Master's degree in Computer Science, Information Technology, or related field
  • 3 years of experience involving computerized system validation per FDA 21 CFR part 11 guidance for GXP systems
  • Biotech industry experience and working with GxP computer systems in a regulated environment
  • Experience working with business clients to understand business processes and suggest solutions
  • IS change control process and building, validating, and supporting GxP systems
  • Planning, executing, and documenting validation activities in compliance with Computer System Validation (CSV)
  • Defining automation testing strategy with an inhouse automation framework
  • Conducting user acceptance testing sessions and ensuring the system is built per business needs

Benefits

  • Comprehensive employee benefits package
  • Discretionary annual bonus program
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models
  • Retirement and Savings Plan
  • Group medical, dental, and vision coverage
  • Life and disability insurance
  • Flexible spending accounts
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