Senior Commissioning & Qualification Engineer

CAI

🇮🇪 Ireland

On-site

Senior

7 months ago

FMEA
GMP

7 months ago

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CAI OverviewAre You Ready?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. Job Title: C&Q EngineerLocation:LimerickContract Type:Staff or Contract Job SummaryWe are seeking Senior Commissioning & Qualification (C&Q) Engineers with strong hands-on experience across both upstream and downstream bioprocessing to support a large-scale, high-profile biopharma project.The core focus of this project is the commissioning and qualification of bioreactor systems, ranging from small-scale units up to large commercial-scale systems. The role also includes upstream and downstream process equipment, supporting material flow through filtration and concentration systems, resulting in small-volume, high-value product that is shipped to Western Europe for final drug product manufacturing.This is a high-impact, technically challenging role, ideal for senior-level C&Q professionals seeking involvement in cutting-edge biomanufacturing projects. Key Responsibilities· Lead and execute full lifecycle Commissioning & Qualification (C&Q) activities for upstream & downstream process equipment.· Commission and qualify bioreactor systems, ranging from small development scale to large commercial-scale reactors.· Support downstream processing (including: Filtration systems (TFF / UF / DF), Concentration and purification systems.· Review and execute C&Q documentation (including: Commissioning Plans, System Impact Assessments (SIA), Risk Assessments (FMEA), IQ, OQ, and PQ protocols, Traceability matrices and final reports.· Ensure all activities comply with GMP regulatory requirements.· Collaborate cross-functionally with Engineering, Automation, Validation, QA, Manufacturing, and Project teams.· Support deviations, change controls, CAPAs, and regulatory inspections. Qualifications· Degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related discipline· 5+ years’ experience in Commissioning & Qualification / CQV / Validation· Strong working knowledge of GMP requirements, FDA and EMA regulations· Strong hands-on upstream and downstream bioprocess knowledge· Extensive experience working with Bioreactors, Filtration and concentration systems· Excellent documentation, communication, and stakeholder engagement skills Other Requirements· This is a site-based role. Must be able to commit to a minimum 40-hour work week, with flexibility based on project needs.· Willingness to travel within Ireland and internationally, if required.· Eligible to work full-time in Ireland. Our approach is simple because our Purpose informs everything we do:We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience. At CAI, we are committed to living our Foundational Principles, both professionally and personally:We act with integrityWe serve each otherWe serve societyWe work for our future At CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing expectations. From the beginning, we’ve challenged ourselves to do what others wouldn’t. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity. For us, operational readiness isn’t simply a goal. It’s a way of life. Because tomorrow demands to be at the forefront of today. We do this through tireless effort, precision, efficiency and an unwavering belief that there is always room for advancement. We’re not interested in how it used to be done. We’re obsessed with how it will be done.

Senior Commissioning & Qualification Engineer · CAI

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