Validation Analyst II, Labs

ICON; 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

Validation Analyst I (Labs)

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

As a Validation Analyst II, Labs at ICON, you will ensure the accuracy, reliability, and compliance of laboratory processes and systems supporting clinical trials.

What You Will Do:

You will take responsibility for quality assurance and compliance deliverables, applying your skills to ensure quality and efficiency.

Key responsibilities include:

• Collaborating with laboratory and quality assurance teams to develop and execute validation protocols and test plans for laboratory instruments, equipment, and software systems.
• Conducting validation testing, data analysis, and documentation in accordance with regulatory requirements and industry standards.
• Identifying and troubleshooting validation issues, deviations, and Nn-conformances, and implementing corrective and preventive actions as needed.
• Providing technical expertise and guidance on validation strategies, best practices, and regulatory expectations to project teams and stakeholders.
• Contributing to the continuous improvement of laboratory processes, systems, and validation methodologies.

Your Profile:

You will bring relevant quality assurance and compliance experience, along with the following qualifications and skills.

Required qualifications and experience:

• Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field.
• Minimum of 2 years of experience in laboratory validation, quality assurance, or related role within the pharmaceutical, biotechnology, or clinical research industry.
• Strong understanding of regulatory requirements (e.g., FDA, EMA, ICH) governing laboratory operations and validation activities.
• Proficiency in validation methodologies, documentation practices, and quality management systems.
• Excellent analytical, problem-solving, and communication skills, with the ability to work effectively in a cross-functional team environment.
• Willingness to travel as required (approximately 5%)

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here