Night Shift CQV Engineer

Position: Night Shift CQV Engineer Location: Colombus, Ohio Fully Onsite Duration: 6 months with possible extension Hours per week: 40 Night Shift (10 PM 6 AM) Job Description: We are seeking a CQV Process Development Engineer to support commercial GMP manufacturing operations on night shift. This engineer will drive the development, characterization, optimization, and validation of automated and semi-automated combination product assembly and packaging processes. This is a hands-on technical leadership role for someone who can work the floor, troubleshoot in real time, and independently draft the protocols and documentation required to keep validation activities on track. Skills: Mechanical design background (degree required) with the ability to assess equipment performance and propose design/process improvements for assembly and packaging line equipment (assemblers, labelers, cartoners, etc.) Proficiency in SolidWorks or similar CAD software for creating, modifying, and printing mechanical drawings and part/fixture designs Hands-on leadership of Commissioning, Qualification, and Validation (CQV) activities in GMP-regulated biotech or pharmaceutical manufacturing environments Direct experience supporting packaging equipment, combination products, and/or device assembly processes Ability to both execute in the field and author protocols, reports, and technical validation documentation Comfort working independently on night shift and making sound technical decisions with limited oversight Experience using KNEAT, Veeva, TrackWise, or similar electronic quality/document management systems Experience with critical process parameter assessment, optimization, and process performance monitoring Ability to lead deviation investigations, root cause analysis, and continuous improvement efforts Experience authoring, executing, and/or approving CQV protocols and reports, Validation Master Plans, Validation Plans, and Summary Reports Strong technical leadership as an SME for combination products, device assembly technologies, and GMP manufacturing processes Reliable availability for weekday and weekend night shifts as required by manufacturing schedules Working knowledge of mechanical systems and components on final drug product packaging lines, with the ability to troubleshoot equipment-level issues alongside engineering and OEM teams Experience recommending or supporting line/equipment modifications to improve throughput, reliability, or product/device handling on assembly and packaging equipment #J-18808-Ljbffr Fusion Life Sciences