CQV Downstream Lead

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 Overview

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.

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

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.