Find Development manager content engineering Jobs in Dublin, D

Validation Engineer
CAI —Dublin, County Dublin
- Full-time
- Engineering
- Bachelor's degree
- Communication skills
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Validation Engineer

CAI -
Dublin, County Dublin

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Job details

Full-time

Qualifications

Engineering
Bachelor's degree
Packaging
Communication skills

Full job description

Validation Engineer – Senior

________________________________________

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.

________________________________________

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

________________________________________

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.

________________________________________

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.

________________________________________

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.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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Refine Your Search

development manager content engineering jobs in dublin, d

Validation Engineer

Maintenance Engineer

BIM Designer - MEP, Design Services

Legal Product Counsel (Relocation to Milan/Luxembourg)

Senior QA Automation Engineer (AI-First)

Sr. Manufacturing Test Engineer, AWS Rack Mfg Operations

Product Lifecycle Mechanical Engineer, Data Center Mechanical Solutions

HV/MV Senior Electrical Design Engineer, AWS HVDE Design Engineering EMEA

Senior Full Stack Engineer - Team Web

Sr. Solutions Consultant

Optical NDE II, Optical Long Haul Network Deployment

Sr. Product Design Engineer, Data Center Engineering - Electrical Products and Services

Associate Business Developer , Data Center Supply Solutions EMEA, Data Centre Supply Solutions

Principal Security Engineer, AWS Security

Sr.Quality Assurance Engineer (German/French Speaking), Alexa Global Quality Team

ICT Design Engineer, EMEA

Director, Web Platform & Technology

Structural Sales Engineer

Sales Engineer Liquid Cooling

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