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Validation Engineer

United Pharma

Burnsville · On-site Contract 1w ago

About the role

About

The Validation Engineers will support installation oversight, commissioning, and full qualification of these systems.

Key Responsibilities

  • Author, review, and execute IQ (Installation Qualification) protocols
  • Author, review, and execute OQ (Operational Qualification) protocols
  • Support PQ (Performance Qualification) execution
  • Verify installation against URS and design specifications
  • Perform utility verification (compressed air, vacuum, electrical, etc.)
  • Validate mechanical, pneumatic, and servo-controlled systems
  • Verify safety interlocks and emergency stop functionality
  • Validate servo motor calibration and motion profiles
  • Challenge alarm conditions and fault recovery scenarios
  • Validate vision inspection systems and reject logic
  • Document deviations and author discrepancy reports
  • Interface with OEM engineers during SAT and troubleshooting
  • Ensure compliance with 21 CFR Part 11 (where applicable)
  • Coordinate with QA for protocol approvals and final validation

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