Downstream CQV Lead – Biopharma Commissioning Expert

Cagents; Limerick; On-site; EUR 90,000 - 130,000; Full time

Job summary

CAI is hiring a CQV Downstream Lead to manage commissioning and qualification activities across downstream process systems on a major biopharmaceutical manufacturing project. This high-visibility leadership role owns CQV delivery from design review through IQ/OQ/PQ and handover to Operations.

You will lead end-to-end CQV for downstream technologies, drive readiness, oversee documentation, and coordinate across Engineering, QA, Automation, Ops and Vendors, mentoring CQV team members.

Qualifications

• 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

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

Skills

CQV Leadership

Biopharma CQV

Stakeholder Management

On-site Leadership

Education

Degree in Engineering/Biotechnology

Job description

CAI is hiring a CQV Downstream Lead to manage commissioning and qualification activities across downstream process systems on a major biopharmaceutical manufacturing project. This high-visibility leadership role owns CQV delivery from design review through IQ/OQ/PQ and handover to Operations.

You will lead end-to-end CQV for downstream technologies, drive readiness, oversee documentation, and coordinate across Engineering, QA, Automation, Ops and Vendors, mentoring CQV team members.