Senior Validation Process Development Engineer

Start Date: August 24

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