Commissioning Agents Inc.

Validation Engineer – Senior

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CAI Overview:

Are You Ready?

CAI is a professional services company established in 1996 that has grown year over year to nearly 700 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide commissioning, qualification, validation, start-up, project management, and consulting services related to operational readiness for FDA-regulated and other mission-critical industries.

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 integrity
• We serve each other
• We serve society
• We 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.

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Job Title UKG: Validation Engineer

Alternate Job Title: N/A

Department: Commissioning, Qualification & Validation

Reports To: Senior Validation Manager

Job Type: Full-Time

Location: Dublin, Ireland

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Job Summary:

Lead commissioning, qualification, and validation activities for packaging and combination product assembly lines, ensuring compliance with GMP, data integrity, and regulatory expectations. Support project teams by developing and executing validation protocols, managing documentation, coordinating resources, and ensuring timely delivery of CQV activities. Engage early in projects to provide design input, vendor coordination, and risk mitigation, while partnering with cross-functional teams to achieve right-first-time outcomes.

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Key Responsibilities:

Support C&Q Team Activities

• Lead end-to-end validation activities in a GMP environment with a focus on safety, quality, and compliance.
• Plan and execute qualifications, oversee FAT/SAT and commissioning activities, and manage deviations/CAPAs.
• Partner with Engineering, Operations, QA, and IT teams to troubleshoot and resolve issues.

Documentation and Procedure Support

• Create and review validation documentation including Validation Master Plans (VMPs), URS, IQ/OQ, IV/FV, FV, and PQ protocols.
• Ensure all documentation is audit-ready and compliant with ALCOA+ principles and data integrity expectations.

Equipment Qualification and Testing Support

• Qualify packaging equipment such as vial labellers, cartoners, carton labelling systems, vision systems, printers/coders, and associated handling/inspection equipment.
• Validate serialization and aggregation systems, ensuring data accuracy and regulatory compliance.
• Support design reviews, shakedown, commissioning, FAT, and IQ/OQ/PQ activities.

Project Planning and Progress Tracking

• Support scoping, planning, and execution of validation projects, ensuring alignment with project schedules.
• Lead vendor and stakeholder engagement during FAT/SAT activities to meet project deliverables.
• Validate market-specific packaging formats, covering artwork, label content, pack configuration, tamper evidence, variable data, and serialization rules.

Deviation and CAPA Control

• Investigate issues, perform structured root cause analysis (5-Whys, fault-tree analysis), and implement corrective actions.
• Ensure timely CAPA closure and update change control documentation as needed.

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Qualifications:

• Bachelor’s degree (BS/BA) in Engineering preferred; relevant experience may substitute for education.
• Minimum 5–10 years of experience in validation roles within the Pharmaceutical/Life Sciences industry.
• Strong knowledge of packaging equipment, inspection systems, and serialization/aggregation solutions.
• Deep understanding of GMP regulations and data integrity (ALCOA+).
• Experience in risk-based validation methods and structured RCA.
• Strong problem-solving, planning, and organizational skills.
• Excellent oral and written communication skills.
• Willingness to collaborate across cross-functional teams and support multiple projects simultaneously.

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Preferred Qualifications:

• Technical degree in Engineering.

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Leadership Competencies:

Deliver Business Growth Strategies

• Supports initiatives to balance short- and long-term business goals.
• Aligns team priorities with broader organizational strategies.

Apply Commercial Insights

• Demonstrates understanding of financial and risk factors impacting business.
• Supports ongoing risk management.

Focus on Customers

• Promotes a customer-focused environment.
• Supports meeting and anticipating customer needs.

Lead Execution

• Maintains accountability and encourages managed risk-taking.
• Keeps teams focused and aligned on objectives.

Influence and Engage Others

• Collaborates effectively and cultivates organizational networks.
• Supports positive negotiation and communication.

Build Talent

• Pursues skill development and supports team growth.
• Promotes diversity and inclusiveness.

Achieve Results with People

• Inspires commitment and high performance.
• Encourages continuous learning and improvement.

Lead Courageously and Safely

• Supports a safe, ethical, and inclusive culture.
• Upholds integrity and leads by example.

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CAI is an equal opportunity employer, proud to employ veterans and promote diversity in our workplace. We pledge to operate fairly and equitably for all employees, customers, and the broader society. This job description is not all-inclusive; other duties may be assigned.

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