QA Validation Engineer — CQV in Biotech (Ireland)

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

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.