Validation Analyst I

Regulatory Toolkit; Village of Farmingdale (NY); On-site; USD 60,000 - 85,000; Full time

Job summary

ICON is a global healthcare intelligence and clinical research organisation focused on bringing new medicines to patients faster. The Validation Analyst I (Labs) role supports validation studies, data import, and library maintenance to streamline processes and ensure quality.

Travel is limited to under 5% domestically or internationally, and responsibilities include coordinating validation activities and assisting the laboratory team under supervision.

Qualifications

• 3+ years medical laboratory experience.
• Prior experience as a Medical Technologist, Biomedical Scientist, Lab Technician, or similar.
• Bachelor's degree in clinical laboratory science or similar degree preferred.
• Knowledge of laboratory techniques, instrumentation, and quality control procedures.
• Experience working in a clinical laboratory or research setting is required.
• Excellent communication skills and the ability to work effectively in a team environment.
• Attention to detail, critical thinking, and problem-solving abilities.

Responsibilities

• Assist in the preparation of validation plans and reports and in performance of results analysis.
• Prepare accuracy, precision, correlation, or stability samples for validation studies.
• Distribute and/or ship validation, correlation, or stability samples within or to ILS owned facilities and/or collaborators.
• Assist in coordinating the performance and completion of validation studies in a timely manner.
• Import data as needed into a statistical analysis tool such as EP evaluator or equivalent.
• Maintain a readily accessible, up to date electronic library of completed validation, correlation, or stability study statistical experiments.
• Be available to assist laboratory in assay validation experiments as necessary.
• Perform other relevant tasks depending on the needs of the global validation department.
• Responsible for the performance of required manual procedures and operation of automated instrumentation under supervision of the Manager or Laboratory Director as necessary.

Skills

Medical Laboratory experience

Teamwork

Attention to detail

Critical thinking

Problem-solving

Communication skills

Education

Bachelor's degree in clinical laboratory science

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.

Job Description:

• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Travel (approximately less than 5%) domestic and/or international.
• Accept direction from Manager and or Scientific Director of Global Validation.

Key Duties:

• Assist in the preparation of validation plans and reports and in performance of results analysis.
• Prepare accuracy , precision, correlation, or stability samples for validation studies.
• Distribute and/or ship validation, correlation, or stability samples within or to ILS owned facilities and/or collaborators.
• Assist in coordinating the performance and completion of validation studies in a timely manner.
• Import data as needed into a statistical analysis tool such as EP evaluator or equivalent.
• Maintain a readily accessible, up to date electronic library of completed validation, correlation, or stability study statistical experiments.
• Be available to assist laboratory in assay validation experiments as necessary.
• Perform other relevant tasks depending on the needs of the global validation department.
• Responsible for the performance of required manual procedures and operation of automated instrumentation under supervision of the Manager or Laboratory Director as necessary.

Qualifications:

• 3+ years Medical Laboratory experience
• Prior experience as a Medical Technologist, Biomedical Scientist, Lab Technician, or similar
• Bachelor's degree in clinical laboratory science or similar degree preferred.
• Knowledge of laboratory techniques, instrumentation, and quality control procedures.
• Experience working in a clinical laboratory or research setting is required.
• Excellent communication skills and the ability to work effectively in a team environment.
• Attention to detail, critical thinking, and problem-solving abilities.

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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 request here.