Jobs → Engineering → CQV Engineer

About the Role We are seeking a CQV Engineer to join our team, focusing on analytical instrument qualification in a GMP-regulated environment. Key Responsibilities • Qualify analytical instruments and laboratory computerized systems • Develop and execute DQ/IQ/OQ/PQ protocols • Manage user requirements, risk assessments, and acceptance criteria • Handle deviations, CAPAs, change controls, calibration, and requalification Requirements • 10+ years of experience qualifying analytical instruments in GMP environments • Hands-on experience with DQ/IQ/OQ/PQ protocols • Experience with HPLC, GC, LC-MS, UV-Vis, FTIR, dissolution systems, balances, and pH meters • Knowledge of instrument software, audit trails, electronic records, user access, and data integrity controls • Familiarity with USP 1058, cGMP, GDP, CSV, and 21 CFR Part 11 • Bachelor’s degree in Engineering, Chemistry, Life Sciences, or related field • Currently based in the USA and available to work onsite in MA