Validation Engineer

CAI

Boston, MA0–4 yrs42m agovia LinkedIn

Key Responsibilities

  • Develop documentation for CQV activities
  • Write and execute protocols (field verification)
  • Develop summary reports at client sites

Areas of Focus

  • Pharmaceutical facilities
  • Utilities
  • Equipment

Project & Team Management

  • Plan and coordinate work
  • Direct small teams in document development and/or execution

Qualifications & Experience

  • Bachelor’s degree in a science or engineering field (or equivalent experience)
  • 0 - 4 years’ experience in commissioning and qualification in a regulated industry
  • Familiarity with ISPE Baseline Guide 5 (Second Edition) is a plus
  • Preferred experience in:
  • Facilities and equipment startup
  • Walk-downs and troubleshooting
  • Utilities (WFI, RO, HVAC)
  • Upstream/downstream processing
  • Purification, recovery
  • Building automation
  • Pharmaceutical manufacturing processes

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