Transformation Project Qualification Lead

Added
17 minutes ago
Type
Full time
Salary
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Related skills

risk management project management validation fmea commissioning

📋 Description

  • Lead EFU and Automation Qualification sub-teams on a strategic capital project
  • Manage schedule, execution, risk, and reporting for teams
  • Plan and complete tasks for commissioning, qualification and validation
  • Develop User Requirements and Functional/Design Specs for equipment and facilities
  • Support Factory Acceptance Testing with Project Engineer
  • Lead risk management activities and ensure alignment with Validation Master Plan

🎯 Requirements

  • Bachelor’s Degree in Engineering/science or equivalent, 3+ years engineering/operational exp
  • Experience in commissioning, qualification, validation and risk deliverables
  • 6+ years in Manufacturing/Quality/Engineering; 4 major validation subjects
  • Technical background in healthcare/pharma or related industries (preferred)
  • Strong interpersonal and negotiation skills, team collaboration
  • Knowledge of quality/compliance standards affecting API/finished goods
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