CQV Downstream Lead

CAI; Limerick; On-site; EUR 80,000 - 100,000; Full time

Benefits offered by this job

Impactful leadership role in high-stakes projects

Exposure to cutting-edge technologies

Engagement with clients and stakeholders

Job summary

CAI is seeking a CQV Downstream Lead in Limerick, Ireland, to manage commissioning and qualification activities for biopharmaceutical manufacturing. This leadership role is pivotal in overseeing downstream CQV delivery from system design to handover to operations.

The ideal candidate will possess a degree in Engineering or Biotechnology and have over 7 years of CQV experience in biopharma, with a strong focus on downstream processes. Join a high-performing team and lead significant project milestones.

Qualifications

• 7+ years of experience in CQV with a strong focus on downstream processes.
• Proficient in CQV documentation, deviations, and change control.
• Strong stakeholder and leadership skills on-site.

Responsibilities

• Lead end-to-end CQV for downstream systems including design and execution.
• Own downstream technologies such as chromatography and filtration.
• Execute risk-based CQV strategy and manage deviations.

Skills

CQV experience in biopharma

Stakeholder management

On-site leadership

Education

Degree in Engineering or Biotechnology

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