Validation Engineer

Job Title: Validation Engineer - Senior

Location: Dublin, Ireland

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.

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.

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.

Preferred Qualifications

• Technical degree in Engineering.

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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