Downstream CQV Lead for Biopharma Systems

CAI; Munster; On-site; EUR 90,000 - 120,000; Full time

Job summary

CAI in Ireland is seeking 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 downstream CQV delivery from design review and risk assessment through IQ/OQ/PQ and handover to Operations. You will coordinate across Engineering, QA, Automation, Ops and Vendors, lead and mentor CQV team members, and drive right-first-time delivery.

Qualifications

• 7+ years CQV experience in biopharma with strong downstream focus.
• Experience with IQ/OQ/PQ documentation and GMP standards.
• Strong stakeholder management and on-site leadership abilities.

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 per GMP, Annex 15, ASTM E2500.
• Lead IQ/OQ/PQ execution and ensure right-first-time delivery.
• Oversee CQV documentation (plans, risk, protocols, reports).
• Coordinate across Engineering, QA, Automation, Ops, Vendors.
• Lead and mentor CQV team members.

Skills

CQV leadership

Biopharma experience

Downstream CQV

Stakeholder management

On-site leadership

Education

Engineering or Biotechnology degree

Tools

CQV documentation tools

Validation protocols

Job description

CAI in Ireland is seeking 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 downstream CQV delivery from design review and risk assessment through IQ/OQ/PQ and handover to Operations. You will coordinate across Engineering, QA, Automation, Ops and Vendors, lead and mentor CQV team members, and drive right-first-time delivery.