On-site Labs Validation Analyst: Quality & Compliance

Regulatory Jobs; Village of Farmingdale (NY); Presencial; USD 62.000 - 78.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Base salary incentives

Health coverage

Retirement plan

Life and disability insurance

Training and development

Wellbeing resources

Descripción de la vacante

ICON is a global healthcare intelligence and clinical research organisation dedicated to bringing new medicines to patients faster. The Validation Analyst, Labs in Farmingdale, NY, on site, will ensure laboratory processes and systems meet regulatory expectations.

You will develop and execute validation protocols, analyze data, document results, and guide project teams on validation strategies to support clinical trials and continuous quality improvements.

Formación

• Bachelor's degree in Life Sciences, Engineering, 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%)

Responsabilidades

• 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 non-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.

Conocimientos

Analytical thinking

Problem solving

Communication

Cross-functional collaboration

Travel willingness

Educación

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

Descripción del empleo

ICON is a global healthcare intelligence and clinical research organisation dedicated to bringing new medicines to patients faster. The Validation Analyst, Labs in Farmingdale, NY, on site, will ensure laboratory processes and systems meet regulatory expectations.

You will develop and execute validation protocols, analyze data, document results, and guide project teams on validation strategies to support clinical trials and continuous quality improvements.