- Full Time
- Limerick
Cagents at a glance
SEC filings mentioning "Cagents": 1 — search EDGAR
Cagents
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
- 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
To apply for this job please visit jobs.lever.co.
Explore Cagents online
What people say about Cagents
- Show HN: cAGENTS – Context-aware AGENTS.md from templates
- Recall going back into Windows
- AWS Price Reductions and Free Inbound Data Transfer
Recent news
- CAI Announces CEO Succession - PR Newswire
- Hillstream BioPharma Signs an Exclusive Option Agreement to - GlobeNewswire
- CAI and Fedegari Group Forge Strategic Partnership to Deliver Transformational Turnkey Sterilization Solutions to Pharmaceutical Manufacturers - Business Wire
- UPDATED: Nationwide to Adopt Bold Penguin's Digital Portal Tech For Commercial Lines P/C Agents - Carrier Management
- CAI Announces the formation of CAI Professional Services India Private Limited. - PR Newswire
Aggregated from public discussions and news; opinions are the authors’ own.
Working in Limerick
Weather right now in Limerick: checking… · Local time: · Air quality: · Daylight: · UV index:
Limerick is a city in western Ireland, in County Limerick. It is in the province of Munster and is in the Mid-West which comprises part of the Southern Region. With a population of 102,287 at the 2022 census, Limerick is the third-most populous urban area in Ireland, and the fourth-most populous city on the island of Ireland. It was founded by Scandinavian settlers in 812, during the Viking Age.
- Elevation 13m (43 ft)
Job details above are provided by the employer/source. The sections on this page are compiled from public data sources with AI assistance.
Accommodations: if you need a workplace accommodation to apply for or perform this job, see ADA.gov or EEOC.gov for guidance on your rights and how to request one.
Keep exploring on Get A Job.ai
Not quite the right fit? Your next opportunity is a click away.
- Browse all jobs
- More jobs by category
- Remote jobs you can do from anywhere
- Research typical pay for this role
- Set a job alert so new matches reach you first
- Upload your resume to apply faster
Hiring instead? Post a job and reach candidates searching right now.