Validation Engineer 2

Illumina
San Diego, CA
Category Engineering
Job Description
Validation Engineer 2 works as an integral part of the validation team, supporting new product introduction, sustaining manufacturing, computerized system introduction / sustaining. Collaborates in a dynamic team-oriented environment and leads the effort for defining, implementing and maintaining validation for manufacturing processes and systems.

Requirements

  • Develops and articulates robust strategies for validation of processes/systems and generate validation plans
  • Develops validation protocols for and oversee execution of IQ, OQ, PQ and manufacturing processes, systems and equipment in collaboration with end users and process owners
  • Writes reports summarizing validation study results and statistics for manufacturing process, systems and software validation projects
  • Writes and executes manual tests for software and system validation
  • Analyzes and documents test results and generate validation reports
  • May operate a variety of laboratory instrumentation and simulators to perform integration testing, system testing, and functionality testing with new software
  • May assist software developers and domain experts in designing, performing, and improving verification tests
  • Provides input for creation of requirements documents
  • Learns, understands, and applies technologies pertinent to systems, processes and products; engage in technical discussions as required
  • Participates in creation of risk management documents such as FMEA for systems and processes
  • Ensures validation program meets requirements of FDA (21 CFR Part 11) and applicable international standards (e.g. ISO-13485)
  • Collaborates with cross-disciplinary project teams to meet project milestones and end goals
  • Provides consultation to other departments performing validation activities
  • May lead cross-functional teams to address software and system level issues
  • Initiates, updates, and/or approves controlled document change requests
  • Performs other related tasks assigned by the supervisor

Benefits

  • Access to genomics sequencing
  • Family planning
  • Health/dental/vision
  • Retirement benefits
  • Paid time off
]]>