CQV Downstream Lead

CAI • Limerick, PA

7d

About The Position

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.

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

Nice To Haves

• 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

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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior