Validation Engineer

Ellab Ireland; Dublin; On-site; EUR 45,000 - 55,000; Full time

Benefits offered by this job

21 Days Annual Leave

Company Pension – Employer matches 5%

Employee Assistance Programme.

Income Protection Benefit.

Death in Service Benefit.

Job summary

Ellab Ireland in Dublin is seeking a Validation Engineer to join our growing team supporting GMP-compliant validation across pharmaceutical manufacturing. You will design, write, and execute IQ/OQ/PQ protocols, perform cleaning validation, and contribute to lifecycle management of GMP systems.

The role emphasizes meticulous documentation, data integrity, and collaboration with cross-functional teams, ensuring equipment, processes, and utilities meet regulatory requirements and product quality

Qualifications

• Strong understanding of GMP regulations and validation principles.
• Experience writing and executing validation protocols (IQ/OQ/PQ).
• Familiar with deviation management and change control processes.

Responsibilities

• Develop and execute validation protocols (IQ/OQ/PQ) for equipment and processes.
• Coordinate and oversee cleaning validation studies and sampling.
• Maintain and update validation lifecycle documentation per GMP.
• Provide recommendations for improvements in cleaning/manufacturing processes.

Skills

IQ/OQ/PQ execution

GMP compliance

Validation documentation

Communication skills

Education

Applied Pharmaceutical / Biological / Chemical sciences

Job description

Job Title: Validation Engineer

Join Ellab on our exciting growth journey! We are seeking Validation Engineers for a client site in the Dublin area.

About Ellab

Ellab is a complete solutions provider covering validation services, calibration services, monitoring, and temperature mapping systems along with a comprehensive Instrumentation Product portfolio. With over 100 employees in Ireland and offices in Cavan and Cork, our specialist teams work with over 250 clients in Ireland, and we’re trusted partners to the world's largest pharmaceutical companies.

Ellab Ireland Validation Engineers work across the Pharmaceutical and Biotech sectors and with the contractors and manufacturers allied to these industries.

Role Overview

The successful candidate is responsible for ensuring that equipment, systems, and processes used in regulated manufacturing environments are properly designed, tested, and maintained in a validated state in line with GMP and regulatory requirements.

The role involves planning, writing, and executing validation documentation such as validation plans, protocols (IQ/OQ/PQ), and reports. It includes supporting qualification of new and existing equipment, utilities, and/or computer systems, ensuring they consistently perform as intended.

Overall, the role focuses on ensuring product quality, patient safety, and regulatory compliance through robust validation practices and lifecycle management of GMP systems.

Key Responsibilities

• Develop and execute cleaning validation protocols (IQ/OQ/PQ where applicable)
• Coordinate and oversee cleaning validation studies and sampling (swab/rinse)
• Cleaning Cycle Development & Performance Qualification protocols for upstream/downstream processes
• Taking accurate and consistent rinse and swab samples
• Assessment of cleaning issues during study runs
• Ensure compliance with GMP, FDA, and EU regulatory requirements
• Maintain and update validation lifecycle documentation
• Provide recommendations for improvements in cleaning / manufacturing processes.
• Write technical cleaning evaluations as requested, including calculations, and deviations with root cause and impact assessment.
• Support audits and inspections (internal and external)

Qualifications & Experience

• Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence
• Candidates should have a strong understanding of GMP regulations and validation principles, including experience writing and executing validation protocols (IQ/OQ/PQ), deviation management, and change control processes.
• Excellent communication, leadership, and organisational skills.

Soft Skills

• Strong attention to detail
• Excellent communication skills
• Problem-solving and analytical thinking
• Ability to work cross-functionally
• Time management and organisation
• Proactive and adaptable mindset

What We Offer

• The opportunity to join a dynamic and rapidly growing company on a steep growth curve.
• A supportive and collaborative work environment where you can make a real impact.
• Market Leading salary and benefits package.
• Opportunities for professional development and growth.
• 21 Days Annual Leave
• Company Pension – Employer matches 5%
• Employee Assistance Programme.
• Income Protection Benefit.
• Death in Service Benefit.

Job Types: Full-time, Permanent

Pay: From €50,000.00 per year

Work Location: In person