CQV Downstream Lead

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CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years. About the Role 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. Responsibilities  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 Requirements Degree in Engineering, Biotechnology, or related  7+ years CQV experience in biopharma (strong downstream focus  Experience with CQV documentation, deviations, change control  Strong stakeholder and on-site leadership skills  Preferred  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  What’s In It For You  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