Night Shift Cqv Engineer

apartmentFusion Life Sciences placeColumbus calendar_month 
Position: Night Shift CQV Engineer (Minitab SME)
Location: Ohio Fully Onsite
Duration: 6 months with possible extension
Hours per week: 40 Night Shift (10 PM 6 AM)

Start Date: September 8th

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. Strong proficiency in Minitab and statistical analysis is essential - candidates must be comfortable performing process capability studies, MSA/Gage R&R, hypothesis testing, and data-driven process optimization as a core part of this role.
Skills:
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

Strong hands-on proficiency with Minitab required - must have demonstrated experience performing statistical analysis including process capability (Cp/Cpk), MSA/Gage R&R, hypothesis testing, regression analysis, and DOE in support of process characterization and validation activities

Experience using KNEAT, Veeva, TrackWise, or similar electronic quality/document management systems

Experience with critical process parameter assessment, optimization, and process performance monitoring - supported by robust statistical methodology
Ability to lead deviation investigations, root cause analysis, and continuous improvement efforts using data-driven and statistical approaches
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

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