CQV Downstream Lead
Core
Lead end-to-end Commissioned Qualification and Validation (CQV) for downstream process systems in a major biopharmaceutical manufacturing project, ensuring GMP compliance from design review through handover to Operations.
Role type
Senior IC CQV Lead (Downstream)
Builds
Biologics manufacturing facilities and downstream purification systems
Domain
Life Sciences / Biopharmaceuticals / Manufacturing Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
downstream CQV execution, chromatography systems, UF/DF/TFF, filtration, CIP/SIP, risk-based validation strategy, GMP compliance, deviation management, change control, CAPA management, stakeholder leadership
Preferred skills
large capital project leadership, single-use systems, skids, automation interfaces, audit/inspection support
Technologies
chromatography, UF/DF/TFF, filtration, CIP/SIP
Responsibilities
Lead end-to-end CQV for downstream systems (design, IQ/OQ/PQ, handover), Drive system readiness (walkdowns, punch lists, FAT/SAT, startup), Execute risk-based CQV strategy (GMP, Annex 15, ASTM E2500), Lead IQ/OQ/PQ execution, Oversee CQV documentation (plans, risk, protocols, reports), Manage deviations, change control, CAPAs, inspection readiness, Coordinate across Engineering, QA, Automation, Ops, Vendors, Lead and mentor CQV team members
Seniority
Senior, hands-on IC
