Jobs → Customer Support → CQV Project Lead

About the Role We are seeking a CQV Project Lead with extensive experience in automation validation and CSV in GMP-regulated environments. This role requires strong leadership skills and technical expertise in validation processes. Key Responsibilities • Lead CQV projects and manage cross-functional teams • Develop and implement validation plans, risk assessments, and test protocols • Ensure compliance with GMP, GAMP, and 21 CFR Part 11 regulations • Manage deviations, CAPAs, change controls, and system startups • Utilize electronic validation management systems like Kneat Requirements • 10+ years of CQV, automation validation, or CSV experience in GMP-regulated environments • Proven experience leading CQV projects and cross-functional teams • Hands-on experience with PLC-controlled systems, automated manufacturing equipment, and iFIX SCADA • Knowledge of alarms, interlocks, control functions, electronic records, and electronic signatures • Strong knowledge of CSV, GAMP, cGMP, GDP, data integrity, and 21 CFR Part 11 • Experience managing deviations, CAPAs, change controls, shutdowns, cutovers, and startups • Bachelor’s degree in Engineering, Life Sciences, or a related field Important: Candidates must be currently based in the USA and available to work onsite in MA.