Senior Validation Engineer

About CAI

CAI is a global professional services organization founded in 1996 that has expanded to almost 700 employees worldwide. It supports Life Sciences and other mission-critical sectors with commissioning, qualification, validation, start-up, project management, and consulting services that help organizations achieve operational readiness in regulated environments.

The company’s purpose is to be a dependable partner for clients building a better working world and improving the human experience. Its work is guided by the principles of integrity, mutual support, service to society, and preparing responsibly for the future.

CAI emphasizes excellence, innovation, precision, and efficient delivery, with a strong focus on doing things better, not just differently, in environments where quality and readiness are essential.

Role Overview

This Senior Validation Engineer position is based in Dublin, Ireland and sits within the Commissioning, Qualification & Validation function. The role reports to the Senior Validation Manager and is a full-time onsite position.

The main purpose of the job is to lead commissioning, qualification, and validation work for packaging and combination product assembly lines. The role requires strong GMP awareness, data integrity discipline, and the ability to coordinate validation efforts from early design input through to execution and closure.

Core Responsibilities

The role involves driving validation work in regulated manufacturing settings, coordinating commissioning and qualification activities, and ensuring that deliverables are completed to the required standard and timeline.

You will work closely with engineering, operations, quality assurance, and IT teams to resolve technical issues, support right-first-time execution, and keep CQV activities aligned with the wider project plan.

Documentation is a major part of the role, including drafting and reviewing key validation documents such as Validation Master Plans, user requirements, qualification protocols, and performance testing documentation. All records must remain compliant with ALCOA+ and data integrity expectations.

Equipment-focused duties include qualification of packaging and inspection systems such as vial labellers, cartoners, carton labelling units, vision inspection tools, printers/coders, serialization and aggregation platforms, and related handling equipment.

The position also requires project planning support, vendor coordination during FAT and SAT, validation of market-specific packaging formats, and active management of deviations, CAPAs, and change control. Root cause analysis techniques such as 5 Whys and fault-tree analysis are used to investigate issues and implement corrective actions.

Qualifications

A bachelor’s degree in engineering is preferred, although relevant work experience may be accepted in place of formal education.

The ideal candidate brings 5 to 10 years of validation experience within pharmaceutical or life sciences environments, along with strong knowledge of packaging systems, inspection technologies, serialization and aggregation solutions, GMP regulations, and ALCOA+ data integrity practices.

Additional strengths expected in this role include risk-based validation, structured root cause analysis, planning and organization, communication skills, and the ability to work across multiple teams and projects at once.

Preferred Background

A technical engineering degree is listed as a preferred qualification.

Leadership Expectations

The role is also aligned to a set of leadership competencies, including supporting business growth strategies, understanding commercial and risk factors, staying customer-focused, driving execution, influencing and engaging others, developing talent, delivering strong results through people, and leading with courage, safety, ethics, and inclusion.

Additional Information

CAI is an equal opportunity employer and states that it is proud to employ veterans and support workplace diversity. The company also notes that it operates with fairness and equity for employees, customers, and society.

The job description is not exhaustive, and additional duties may be assigned as needed.

The hiring process may use AI-based tools to help review applications, analyze resumes, assess responses, and identify inconsistencies or verification signals. These tools support the recruitment team, but final hiring decisions are made by people. Applicants may contact the company for more information about how their data is handled.