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Engineer III, Validation

Thermo Fisher Scientific

Thermo Fisher Scientific seeks a Validation Engineer III to support commissioning, qualification, and validation activities for pharmaceutical manufacturing equipment and systems in Greenville, North Carolina. The role involves protocol development, cross-functional collaboration, and documentation in an aseptic processing environment.

Responsibilities

  • Plan, author, review and execute commissioning, qualification and validation protocols for equipment, facilities and utilities
  • Verify completion of validation activities and ensure documentation accuracy and cGMP compliance
  • Support qualification and verification of automation controls and computer systems for pharmaceutical equipment
  • Develop risk assessments to determine validation strategy, testing scope and appropriate controls
  • Partner with Engineering, Manufacturing, Quality and Automation teams to execute validation activities

Requirements

  • Bachelor's degree in Engineering, Life Sciences, Chemistry, or related technical field
  • Minimum 5 years validation, CQV, or engineering experience in regulated pharmaceutical/biotech manufacturing
  • Demonstrated experience developing, reviewing and executing validation protocols including IQ/OQ/PQ
  • Working knowledge of cGMP requirements and regulated pharmaceutical manufacturing practices
  • Strong technical writing skills and ability to produce inspection-ready documentation
  • Experience with risk assessment methodologies, problem-solving and root cause analysis
  • Proficiency with Microsoft Office and engineering/validation software tools
Vacancy posted 6 days ago
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