Description

Manage the full lifecycle of validation protocols for facilities, utilities, equipment, and computerized systems.

Responsibilities

• Generate, execute, and oversee IQ/OQ protocols and validation master plans.
• Create validation deliverables including traceability matrices, assessments, and supporting documentation.
• Develop complex validation protocols using a risk-based approach aligned with regulatory standards.
• Analyze results, implement changes, and manage discrepancy and report generation.
• Review vendor validation packages and resolve punch lists through direct vendor communication.

Required Skills

• Master's Degree in Mechanical Engineering.
• 5+ years of experience in commissioning and qualification processes.
• Proficiency in Python and C++.
• Strong troubleshooting capabilities.
• Ability to develop User Requirements, Functional Specifications, and Requirement Traceability Matrices (RTM).
• Willingness to travel or relocate to unanticipated US locations.

Key Skills

Education

Any Graduate