Validation Engineer

Dublin - Ireland

Monthly Salary: Not Disclosed

Posted on: 10 hours ago

Vacancies: 1 Vacancy

Job Summary

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 weve challenged ourselves to do what others wouldnt. 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 isnt simply a goal. Its 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. Were not interested in how it used to be done. Were 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:

Bachelors degree (BS/BA) in Engineering preferred; relevant experience may substitute for education.

Minimum 510 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. 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.

Validation Engineer SeniorCAI Overview:Are You ReadyCAI 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 provi...