CQV Validation Engineer

Demonstrated experience leading Commissioning, Qualification, and Validation (CQV) activities within a GMP-regulated biotechnology or pharmaceutical manufacturing environment, with direct experience supporting packaging equipment, combination products, and/or device assembly processes. Hands-on experience using electronic quality and document management systems, including KNEAT, Veeva, TrackWise, or equivalent platforms for managing validation documentation, change controls, deviations, CAPAs, and quality records. Ability and willingness to be onsite and support manufacturing operations during off-shift hours, including weekday and weekend night shifts, as required to execute validation activities, and support commercial manufacturing schedules. The Senior Validation Process Development Engineer serves as a technical leader responsible for supporting commercial GMP manufacturing operations while driving the development, characterization, optimization, and validation of automated and semi-automated combination product assembly and packaging processes. This role applies advanced engineering principles to ensure robust, compliant, and efficient manufacturing processes that support both commercial production and new product introduction. The engineer provides day-to-day technical support for commercial manufacturing through equipment and process troubleshooting, critical process parameter assessment and optimization, process performance monitoring, deviation investigations, root cause analysis, and implementation of continuous improvement initiatives to enhance product quality, process capability, and operational excellence. Key documentation responsibilities Characterization test protocols and reports Commissioning, Qualification, and Validation (CQV) test protocols and reports for manufacturing equipment, computerized systems, and processes Engineering studies and technical assessments Validation Master Plans, Validation Plans, and Summary Reports Technical reports supporting equipment lifecycle management, process improvements, technology transfers, and new product introductions (NPI) Working cross-functionally with Manufacturing, Quality, Validation, Engineering and other technical organizations, the Senior Engineer leads complex engineering initiatives, resolves technical challenges, and identifies opportunities to improve equipment reliability, process performance, and manufacturing capability. This individual serves as a Subject Matter Expert (SME) for combination products, device assembly technologies, and GMP manufacturing processes, ensuring compliance with regulatory requirements while supporting the successful commercialization and lifecycle management of the business’s product portfolio. Basic Qualifications Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience #J-18808-Ljbffr ACL Digital