Senior Commissioning Qualification Validation Engineer
Core
Lead Commissioning, Qualification, and Validation (CQV) functions to ensure systems, facilities, and equipment meet design requirements for biomedical and pharmaceutical projects.
Role type
Senior IC Commissioning, Qualification, and Validation Engineer
Builds
Commissioned, qualified, and validated facilities, utilities, and equipment for pharmaceutical/biomedical projects
Domain
Biomedical and Pharmaceuticals
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CQV protocols development and execution, DQ/FAT/SAT/IQ/OQ/PQ/PV documentation, SOPS creation, cGMP/CFR21 Part 11 compliance, risk analysis, design review coordination, vendor/contractor management
Preferred skills
Strategic thinking, analytical skills, data-to-action translation, marketing strategy conversion, tactical planning
Technologies
GMP, GDP, cGMP, CFR21 Part 11
Responsibilities
Lead and simplify CQV functions and processes; implement safety programs for capital projects; commission, qualify, and validate facilities/utilities/equipment; author and review controlled CQV documents; coordinate risk analyses, design reviews, and FAT/SAT/IQ/OQ/PQ activities; collaborate with multiple departments and manage contractors/vendors
Seniority
Senior, hands-on IC