Summary from listing
The Process Development Validation Scientist will draft process validation protocols, reports, CPV and PC&P documents, VMP/VSR, manufacturing study protocols, risk-assessment spreadsheets, and PPQ training materials. The role also supports initial and final risk assessments, OOT and OOS/CAPA investigations, and maintains training on company and departmental procedures. Candidates need a science-related bachelor’s degree with 6+ years of experience or a master’s degree with 3+ years of experience, knowledge of ICH GMP and process validation, strong technical writing and Microsoft Office skills, and familiarity with statistics, sampling, data trending, Minitab, and SPC.
