Transformation Project Qualification Lead

📋 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