Validation Analyst II, Labs – Clinical Trials QA & Compliance

KCR Placement; Dublin; On-site; EUR 45,000 - 60,000; Full time

Benefits offered by this job

Health insurance

Annual leave

Retirement planning

Job summary

ICON in Ireland seeks a Validation Analyst I (Labs) to ensure accuracy, reliability, and compliance of laboratory processes for clinical trials. You will collaborate with QA teams to develop validation protocols for instruments, equipment, and software, and perform testing, data analysis, and documentation in line with regulatory expectations.

The role requires a life sciences/engineering/CS background, at least 2 years in lab validation or QA, and strong knowledge of FDA/EMA/ICH standards.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, CS or related field.
• Minimum 2 years in laboratory validation, QA, or related role in pharma/biotech/clinical research.
• Strong understanding of FDA, EMA, ICH regulatory requirements governing labs and validation.
• Proficiency in validation methodologies, documentation practices, and quality systems.
• Excellent analytical, problem-solving, and communication skills with cross-functional teamwork.
• Willingness to travel approximately 5%.

Responsibilities

• Collaborate with laboratory and QA teams to develop and execute validation protocols for instruments, equipment, and software systems.
• Conduct validation testing, data analysis, and documentation per regulatory requirements and industry standards.
• Identify and troubleshoot validation issues, deviations, and non-conformances, and implement CAPA as needed.
• Provide technical guidance on validation strategies, best practices, and regulatory expectations to project teams.
• Contribute to continuous improvement of laboratory processes, systems, and validation methodologies.

Skills

Analytical skills

Problem solving

Communication

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree in Life Sciences, Engineering, CS or related field

Job description

ICON in Ireland seeks a Validation Analyst I (Labs) to ensure accuracy, reliability, and compliance of laboratory processes for clinical trials. You will collaborate with QA teams to develop validation protocols for instruments, equipment, and software, and perform testing, data analysis, and documentation in line with regulatory expectations.

The role requires a life sciences/engineering/CS background, at least 2 years in lab validation or QA, and strong knowledge of FDA/EMA/ICH standards.