Position: Senior Validation Process Development Engineer x2 (Day Shift + Night Shift)
Location: Columbus, Ohio Fully Onsite
Duration: 6 months with possible extension
Hours per week: 40 There are 2 roles here 1 is a Day Shift + Night Shift (10-6)
Start Date: August 24
Job Description: We are seeking an experienced Senior Validation 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:
- 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
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