Equipment Validation Engineer

Irvine, California
Industry: Biotech / Pharma
Job Number: JN -062021-65183

Project Activities

  • Carries out responsibilities in accordance with the organizations policies, procedures, and state and federal and local laws.
  • Assures that protocols are approved through proper channels: Writes and revises validation Protocols
  • Executes Validation protocols per related SOP’s and assures that acceptance criterion related to Validation protocols are met.
  • Assures that all test data is gathered and recorded in accordance with cGMP requirements.
  • Analyze data to ascertain if it meets related protocol acceptance criteria: Writes deviation reports as required upon failures to meet protocol acceptance criteria.
  • Writes reports and assures that they are approved through proper channels.
  • Provides support in investigations and other trouble shooting activities.
  • Interfaces with Quality Assurance, Quality Control, Operation and Engineering to ensure timeline execution and reporting of the plan.

Project Activities

  • resource will generate the following deliverables as part of the work effort:
  • Qualification Protocols
  • Executed IQ/OQ/PQ Protocols
  • Final Reports
  • QEP’s
  • SOP’s
  • Deviation Reports/Failures
  • Other documentation as specified by the client

Ref: #JN -062021-65183

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