CQV Downstream Lead

Job description

CAI Overview Are You Ready? **About Us** 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