Author, review, and execute commissioning and qualification documentation, including User Requirements Specifications (URS), risk assessments, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Working knowledge of Health-Based Exposure Limits (HBEL), Permitted Daily Exposure (PDE), Maximum Allowable Carryover (MACO), swab and rinse recovery studies, HPLC methods, hold-time studies, and cleaning process development.