Key Facts

Remote From:

Full time

Senior (5-10 years)

English

Hard Skills

Engineering Validation Tests FDA Regulations Software Validation Process Validation Data Validation Clinical System Operations Computer System Validation Validation Controls Auditing Project Management Risk Analysis Impact Assessment Cross-Functional Collaboration Project Management Continuous Improvement Process

Other Skills

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Quality Assurance
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Communication
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Teamwork
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Detail Oriented
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Mentorship
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Problem Solving

Roles & Responsibilities

Bachelor's degree in Engineering, Life Sciences, or a related field; a Master's degree is a plus.
Extensive experience in validation engineering within the healthcare, pharmaceutical, or clinical research industries.
Strong knowledge of validation principles, methodologies, and regulatory requirements (GxP, FDA, EMA).
Excellent problem-solving, detail-oriented project management, and cross-functional communication skills.

Requirements:

Design, develop, and execute validation plans, protocols, and reports for systems and processes in accordance with regulatory requirements.
Collaborate with engineering, IT, and quality assurance teams to identify validation needs and establish best practices in validation methodologies.
Conduct risk assessments and impact analyses to evaluate potential effects of changes to systems and processes.
Maintain validation documentation to support audits and inspections, assist QA with sponsor/regulatory requests, and provide mentorship to junior validation engineers.

ICON plc

Pharmaceuticals

About ICON plc

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.

Company type: XLarge

Industry: Pharmaceuticals

Founded: 2018

Company size: 10001

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Job description

Senior Validation Engineer - Blue Bell, PA or Raleigh, NC (Office-Based With Remote Flex)

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are currently seeking a Senior Validation Engineer to join our diverse and dynamic team. As a Senior Validation Engineer at ICON, you will play a crucial role in ensuring that our systems and processes meet the highest standards of quality and compliance. You will collaborate with cross-functional teams to develop and execute validation protocols that support our clinical research operations and enhance operational efficiency. You will be participating in audits and assisting with sponsor support.

What You Will Be Doing:

Designing, developing, and executing validation plans, protocols, and reports for systems, and processes in accordance with regulatory requirements.
Working closely with engineering, IT, and quality assurance teams to identify validation needs and establish best practices in validation methodologies.
Conducting risk assessments and impact analyses to evaluate the potential effects of changes to systems and processes.
Maintaining accurate documentation of validation activities to support audits and inspections, ensuring compliance with GxP and other relevant regulations.
Assisting ICON’s QA department with sponsor and regulatory requests.
Providing mentorship and training to junior validation engineers, promoting a culture of continuous improvement and quality assurance.

Your Profile:

Bachelor’s degree in Engineering, Life Sciences, or a related field; a Master’s degree is a plus.
Extensive experience in validation engineering within the healthcare, pharmaceutical, or clinical research industries.
Strong knowledge of validation principles, methodologies, and regulatory requirements (e.g., GxP, FDA, EMA).
Excellent problem-solving skills, with a detail-oriented approach to project management and execution.
Strong communication skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.

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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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.

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

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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply