Validation Analyst, Labs

ICON plc • Farmingdale, NY

2d • $62,376 - $77,970 • Onsite

About The Position

The Validation Analyst, Labs at ICON is responsible for ensuring the accuracy, reliability, and compliance of laboratory processes and systems that support clinical trials. The role owns quality assurance and compliance deliverables, applying relevant expertise to promote quality and efficiency.

The position is office-based and on site in Farmingdale, New York. It requires approximately 5% travel as needed.

Requirements

• Bachelor's degree in Life Sciences, Engineering, or a related field.
• At least 2 years of experience in laboratory validation, quality assurance, or a related role in the pharmaceutical, biotechnology, or clinical research industry.
• Strong understanding of regulatory requirements, including FDA, EMA, and ICH requirements governing laboratory operations and validation activities.
• Proficiency in validation methodologies, documentation practices, and quality management systems.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work effectively in a cross-functional team environment.
• Willingness to travel as required, approximately 5%.
• Legal right to work in the country where the role is based.

Responsibilities

• Collaborate with laboratory and quality assurance teams to develop and execute validation protocols and test plans for laboratory instruments, equipment, and software systems.
• Conduct validation testing, data analysis, and documentation in accordance with regulatory requirements and industry standards.
• Identify and troubleshoot validation issues, deviations, and non-conformances, and implement corrective and preventive actions as needed.
• Provide technical expertise and guidance on validation strategies, best practices, and regulatory expectations to project teams and stakeholders.
• Contribute to the continuous improvement of laboratory processes, systems, and validation methodologies.

Benefits

• Competitive base salary and performance-related incentives.
• Medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level