CQV/Validation Engineer

About CAI

Founded in 1996 as a fully employee-owned enterprise, CAI has grown to nearly 700 team members worldwide. We specialize in commissioning, qualification, validation, project management, and consulting to prepare FDA-regulated and other critical operations for readiness. Our core philosophy emphasizes client-first service, relentless pursuit of quality, and a commitment to integrity, teamwork, societal benefit, and long-term sustainability. With employee ownership, success is shared, fostering a respectful, dedicated, and collaborative culture that enables clients to access cutting-edge technologies in advanced medicine and benefit from our comprehensive professional services.

Role Overview

We seek a Commissioning, Qualification, and Validation (CQV) Engineer to join our expanding Irish operations. This vital position involves leading and executing CQV efforts with a strong focus on safety, managing all phases of commission and qualification documentation, and ensuring timely delivery of project milestones. The incumbent will draft and approve CQV procedures, facilitate planning for necessary spares and consumables, oversee design reviews, commissioning events including Factory Acceptance Tests (FAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), as well as coordinate activities with contractors and vendors throughout the project lifecycle.

Key Responsibilities

• Lead and conduct commissioning, qualification, and validation tasks prioritizing safety.
• Manage full lifecycle of CQV documentation from System Level Installation Acceptance (SLIA) to successful completion of OQ.
• Create and authorize CQV procedures and Test Operation Procedures (TOPs).
• Plan and allocate spares and consumables required for commissioning activities.
• Track and report CQV progress to align with project schedules.
• Prepare Qualification Summary Reports and maintain Requirement Traceability Matrix.
• Participate in design reviews, shakedown and various qualification stages including FAT, IQ, OQ, and PQ.
• Manage change controls, document control, punch lists, vendor and contractor coordination during project execution.

Requirements

• Bachelor's or Master’s degree in relevant science or engineering discipline or equivalent experience.
• Minimum of 3 years’ specialized CQV experience within life sciences, especially in clean utilities or aseptic filling lines.
• Strong oral and written communication capabilities.
• Excellent analytical and problem-solving skills.
• Customer-oriented mindset.
• Proficient understanding of biotech, aseptic fill/finish, oral solid dose forms (OSD), gene therapy manufacturing processes or equivalent sectors.
• Willingness and availability to travel for domestic and international assignments.

Additional Information

CAI embraces and promotes equal opportunity employment and values diversity as a strategic strength. We are committed to operating fairly for employees, clients, and society. This description is indicative and may include other duties as assigned. In our recruitment process, we utilize AI-assisted tools to analyze application data supporting but not replacing human decisions. For privacy inquiries, applicants are encouraged to reach out.