QA Validation Engineer

CAI; Limerick; On-site; EUR 65,000 - 90,000; Full time

Job summary

CAI is seeking a QA Validation Engineer to support IQ, OQ, and PQ activities for GMP equipment across Ireland’s leading pharmaceutical and biotechnology facilities.

You will prepare validation documents, review lifecycle records, and assist in commissioning, qualification, and validation projects from planning to execution. The role offers exposure to diverse analytical and manufacturing systems within a GMP-regulated environment.

Qualifications

• 3+ years' validation experience in pharma/biotech/life sciences environments.
• Experience qualifying laboratory or manufacturing equipment in GMP-regulated facilities.
• Strong understanding of GMP and validation principles.
• Experience authoring and executing validation documentation.

Responsibilities

• Execute IQ, OQ, and PQ activities for GMP equipment and systems.
• Prepare and review validation protocols, reports, and lifecycle documentation.
• Support commissioning, qualification, and validation projects from planning through execution.
• Perform risk assessments and support deviation, CAPA, and change control activities.
• Ensure compliance with GMP, GDP, and regulatory requirements.
• Collaborate with Quality, Engineering, Manufacturing, and Laboratory teams.
• Participate in audits and inspection readiness activities.
• Support equipment lifecycle management and continuous improvement initiatives.

Skills

IQ/OQ/PQ execution

GMP validation

Technical writing

Stakeholder management

Education

Engineering degree

Biotech degree

Job description

Are you a Validation Engineer looking to work on cutting-edge pharmaceutical and biotech projects in Ireland?

CAI is seeking a QA Validation Engineer to support qualification and validation activities for laboratory and process equipment across leading pharmaceutical and biotechnology facilities. This role offers the opportunity to work with a diverse range of analytical, manufacturing, and GMP-regulated systems while contributing to some of Ireland's most advanced life sciences operations.

Key Responsibilities

• Execute IQ, OQ, and PQ activities for GMP equipment and systems.
• Prepare and review validation protocols, reports, and lifecycle documentation.
• Support commissioning, qualification, and validation projects from planning through execution.
• Perform risk assessments and support deviation, CAPA, and change control activities.
• Ensure compliance with GMP, GDP, and regulatory requirements.
• Collaborate with Quality, Engineering, Manufacturing, and Laboratory teams.
• Participate in audits and inspection readiness activities.
• Support equipment lifecycle management and continuous improvement initiatives.

Requirements

• Degree in Engineering, Science, Biotechnology, or a related discipline.
• 3+ years' validation experience within pharmaceutical, biotechnology, medical device, or life sciences environments.
• Experience qualifying laboratory and/or manufacturing equipment in GMP-regulated facilities.
• Strong understanding of GMP and validation principles.
• Experience authoring and executing validation documentation.
• Knowledge of deviation management, change control, and CAPA processes.
• Excellent communication and stakeholder management skills.
• Strong technical writing and problem-solving abilities.
• Eligible to work in Ireland.

Why Join CAI?

• Work with leading pharmaceutical and biotechnology companies across Ireland.
• Exposure to a wide range of validation and CQV projects.
• Career development within a growing global organisation.
• Collaborative and supportive team environment.
• Competitive salary and benefits package.

About CAI

CAI is a global leader in commissioning, qualification, validation, and operational readiness services for the pharmaceutical, biotechnology, and life sciences industries. We partner with leading manufacturers to deliver compliant, efficient, and innovative solutions that ensure quality and regulatory excellence.