Quick overview
SeniorityMid Senior
Employment typeTemporary/Casual
Work modeOn Site
LocationBoston, Massachusetts, United States
Posted16 hours ago
Root Cause AnalysisTriageProject Management
Job description
Lead the investigations that keep a commercial cell therapy plant running at a leading biotechnology company in Boston, Massachusetts. You will own deviations, CAPAs and change controls end to end in eQMS, from triage and GEMBA to root cause and closure.
What you'll do
- Triage deviations, engage SMEs, set containment and document the initial impact.
- Lead investigations across manufacturing, QC, materials, facilities and equipment.
- Own CAPAs, effectiveness checks and change controls through on-time closure.
- Track deliverables in Smartsheet.
- Bachelor's degree (any field) + 5–10 years of engineering, project management or pharmaceutical experience.
- Independent ownership of complex investigations.
- Root cause analysis tools; eQMS (Veeva, TrackWise or similar).
- Cell therapy or aseptic manufacturing is a strong plus.
- Contract: 12 months, with possible extension
- Shift: On-site; shift set by the hiring manager (may be non-standard)
- Start: November 2, 2026