CQV Downstream Lead

We are hiring a CQV Downstream Lead to manage commissioning and qualification activities across downstream process systems on a major biopharmaceutical manufacturing project. 

This is a high-visibility leadership role where you will own downstream CQV delivery from system design review and risk assessment through execution, qualification (IQ/OQ/PQ), and handover to Operations.

• →Lead end-to-end CQV for downstream systems (design, IQ/OQ/PQ, handover) 
• →Own downstream technologies: chromatography, UF/DF/TFF, filtration, CIP/SIP 
• →Drive system readiness: walkdowns, punch lists, FAT/SAT, startup 
• →Execute risk-based CQV strategy (GMP, Annex 15, ASTM E2500) 
• →Lead IQ/OQ/PQ execution and ensure right-first-time delivery 
• →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

• Experience leading CQV on large capital projects 
• Knowledge of downstream purification (capture, polish, viral filtration)  
• Exposure to single-use systems, skids, or automation interfaces 
• Experience supporting audits / inspections / operational readiness 

• Lead high-impact downstream CQV delivery on a flagship biologics project 
• Work with cutting-edge purification technologies and systems 
• Join a high-performing CQV team on complex, large-scale builds 
• Gain strong visibility with clients and senior project stakeholders 
• Exposure to end-to-end project lifecycle