HireFT
Browse JobsHow it worksPricingAboutSuccess Stories
    Back to jobs
    CA

    CAgents

    Automation Engineering

    CQV Downstream Lead

    Limerick, IrelandOn-SiteFull-timePosted 2mo ago
    All CAgents jobs

    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

    Job details are sourced from the employer's original posting.

    Open job posting
    CA

    About the company

    CAgents

    CAgents is a company focused on automation engineering, particularly within regulated manufacturing environments like pharmaceutical and biotechnology. They specialize in supporting manufacturing automation systems and laboratory/QC equipment, with expertise in GMP change control processes.

    View all CAgents jobs
    Industry
    Automation Engineering
    Open roles
    14

    Interested in this role?

    Apply with HireFT

    Free to start — no card required.

    Your fit

    How well do you match?

    Sign in to see how your résumé lines up with this role.