Senior Validation Engineer

GxP Recruitment; Munster; On-site; EUR 60,000 - 80,000; Full time

Job summary

GxP Recruitment is seeking a Validation Engineer with intermediate to senior-level validation experience for roles in the medical device, pharmaceutical, or regulated manufacturing industries in Ireland. You will execute IQ/OQ/PQ activities, author and review validation protocols and reports, and work within cross-functional teams to ensure quality systems and regulatory compliance.

Active involvement in manufacturing, process improvement and capital projects, with independent management of

Qualifications

• Strong validation experience including IQ, OQ and PQ execution.
• Experience authoring and reviewing validation protocols and reports.
• Knowledge of equipment, process and software validation.
• Familiarity with quality systems, risk management and regulatory requirements.
• Strong problem-solving, technical writing and communication skills.
• Ability to manage validation activities independently within cross-functional teams.
• Support a range of manufacturing, process improvement and capital projects with timely deliverables.

Responsibilities

• Execute IQ, OQ and PQ activities and prepare validation documentation.
• Collaborate with manufacturing and engineering to ensure compliance with regulatory standards.
• Manage validation activities to meet project timelines and deliverables.

Skills

IQ/OQ/PQ execution

Validation protocol writing

Regulatory compliance knowledge

Cross-functional teamwork

Technical writing

Communication skills

Education

Honours Bachelor's degree in Engineering or Science

Job description

We are looking for a Validation Engineer with intermediate to senior-level validation experience, preferably gained within the medical device, pharmaceutical, or other regulated manufacturing industries.

Key requirements include:

• Strong validation experience, including execution of IQ, OQ and PQ activities
• Experience authoring and reviewing validation protocols and reports
• Knowledge of equipment, process and software validation
• Familiarity with quality systems, risk management and regulatory compliance requirements
• Strong problem-solving, technical writing and communication skills
• Ability to manage validation activities independently and work effectively within cross-functional teams
• The contractor will support a range of manufacturing, process improvement and capital projects, ensuring that validation deliverables are completed to a high standard and in line with project timelines.

Education & Experience:

• Honours Bachelor's degree in Engineering or Science is essential.
• Minimum of 3 years’ experience within a manufacturing environment is required.
• Experience with FDA-regulated environments is highly desirable but not essential.
• Familiarity with validation lifecycle processes is required.