$400,000 Per Year
$950,000 Per Year
Executes validation and qualification activities for pharmaceutical manufacturing equipment. Prepares Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. Conducts cleaning validation and prepares cleaning validation protocols and reports. Performs process validation including prospective, concurrent, and retrospective validation. Manages computer system validation (CSV) for manufacturing and laboratory systems. Supports HVAC, water system, and utility validation and requalification activities. Prepares validation master plans and annual product reviews related to validation. Coordinates with QA and production teams for validation scheduling and execution. Reviews equipment calibration programs and supports metrology activities. Manages validation change control and periodic review of validated systems. Prepares technical reports and deviation reports related to validation activities. Supports regulatory inspections with validation documentation and data packages. Stays updated with FDA process validation guidance, Annex 15, and ICH Q10.