Validation Engineer – Medical Devices / Pharmaceuticals

Location: Galway City, Ireland

Are you a Validation Engineer looking for a new opportunity in the thriving medical device or pharmaceutical industry? Our client, a leading organisation in Galway City, is seeking an Associate Validation Engineer to join their dynamic team.

This is a fantastic opportunity for professionals who are passionate about ensuring regulatory compliance, optimising validation processes, and contributing to high-quality projects in a fast-paced, innovative environment.

Key Responsibilities:

Validation Coordination & Execution: Lead and organise the validation of manufacturing systems, software, and processes, ensuring they comply with industry standards, SOPs, and GMPs.

Test Analysis & Reporting: Analyse validation test results, compile comprehensive reports, and present conclusions to key stakeholders, ensuring clarity and actionable insights.

Validation Programme Enhancement: Contribute to the continuous development and improvement of the validation programme, ensuring it meets evolving GMP and regulatory requirements.

Process & System Validation: Work closely with Manufacturing and Automation Engineering teams to execute, document, and optimise process validations. Ensure compliance with relevant standards, such as ISO13485, FDA 21CFR11, PMDA, and GAMP 5.

Software & System Testing: Conduct manual software and system validation tests, documenting results meticulously, and ensuring compliance with FDA, ISO, PMDA, and GAMP 5 guidelines.

Regulatory Consultation & Compliance: Provide early-stage consultation on Computer System Validation (CSV) during project proposal phases, advising on compliance with regulatory requirements.

Documentation & Reporting: Write and maintain validation plans, reports, and procedures in line with internal quality standards and external regulatory expectations.

Essential Qualifications & Experience:

Education: A degree in Engineering or a related Science discipline (Level 8 or higher).

Experience: Minimum of 2-3 years of experience in validation or quality assurance in the medical device or pharmaceutical industry.

Regulatory Knowledge: Solid understanding of ISO13485, FDA 21CFR11, PMDA, and GAMP 5 standards.

Validation Expertise: Experience with test method validation, risk assessments, CAPA, and change control processes.

Technical Skills: Proficient in Minitab (for statistical analysis), PLC programming, and other relevant validation tools.

Software Proficiency: Strong knowledge of Microsoft Office applications (Word, Excel, Outlook).

Communication Skills: Excellent written and verbal communication skills, with the ability to produce clear, accurate reports in English.

Project Management: Ability to manage multiple projects, balancing competing deadlines while maintaining high standards of quality and compliance.

Desirable Skills & Qualifications:

Additional qualifications or certifications in validations or software testing.

Experience in continuous improvement or quality system development.

Why Galway City?

Galway City offers an outstanding quality of life, blending rich cultural heritage with modern amenities, a vibrant community, and easy access to beautiful landscapes and outdoor activities. It’s the perfect location for professionals seeking both career growth and a balanced, fulfilling lifestyle.

“Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters

 

For further information on this role please contact Lisa Lawlor on 0868395533 or email stem@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/  

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.”