Validation Analyst, Labs

Regulatory Toolkit; Village of Farmingdale (NY); On-site; USD 62,000 - 78,000; Full time

Benefits offered by this job

Base salary incentives

Health coverage

Retirement plan

Life and disability insurance

Training and development

Wellbeing resources

Job summary

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.

Qualifications

• 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%)

Responsibilities

• 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.

Skills

Analytical thinking

Problem solving

Communication

Cross-functional collaboration

Travel willingness

Education

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

Job description

Validation Analyst (Labs) - Farmingdale NY - Office-based

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.

Validation Analyst, Labs- Farmingdale NY- on site.

As a Validation Analyst, 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, 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%)

#LI-FL1

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including 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

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a requesthere.

Salary Range

$62,376.00-$77,970.00