Ensure Excellence at the Heart of Clinical Development
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 seeking an experienced Senior Validation Engineer to join our team in Chennai. In this critical role, you will be the cornerstone of our computerized system compliance, ensuring that all IT systems supporting global clinical trials are validated to meet stringent regulatory standards (FDA 21 CFR Part 11, EU Annex 11, GAMP 5). You will lead validation activities for complex, high-impact projects, acting as a subject matter expert and a key representative during client audits.
Your Responsibilities
Strategic Validation Leadership:
- Plan, lead, and execute computer system validation (CSV) and qualification activities for regional and global projects, ensuring full compliance with FDA, MHRA, and other regulatory body requirements.
- Perform critical Risk Impact Assessments (RIA), Data Integrity Risk Assessments, and 21 CFR Part 11 Assessments for GxP systems.
- Represent the Validation Team during sponsor audits and regulatory inspections.
End-to-End SDLC & Testing Oversight:
- Create, execute, and review core validation deliverables: Validation Plans, Test Scripts (IQ/OQ/PQ), Traceability Matrices, and Validation Summary Reports.
- Lead various testing phases including Functional, System, Regression, and User Acceptance Testing (UAT).
- Review all System Development Life Cycle (SDLC) deliverables to ensure adherence to ICON SOPs and industry best practices.
Process Excellence & Compliance Stewardship:
- Conduct Periodic Reviews of validated systems to ensure their state of control is maintained.
- Create, review, and update Standard Operating Procedures (SOPs) and Working Procedures related to the SDLC and validation.
- Develop and deliver training on SDLC processes, validation, and regulatory requirements to internal teams.
- Coordinate validation activities across multiple departments and with external vendors.
Your Profile: Qualifications & Skills
Education & Experience:
- Bachelor’s Degree in Computer Science, Information Technology, Engineering, or a related Life Science field.
- A minimum of 6 years of direct, hands-on experience as a Validation Engineer, specifically within the pharmaceutical, biotechnology, or CRO industry.
- Proven expertise in GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles (ALCOA+).
Technical Skills & Competencies:
- Expert-level experience in leading Installation (IQ), Operational (OQ), and Performance (PQ) Qualification.
- Proficiency in Risk-Based Validation methodologies and tools.
- Strong knowledge of SDLC phases and associated documentation.
- Excellent project management, communication, and stakeholder management skills.
- Ability to manage multiple projects simultaneously in a fast-paced, global environment.
- Willingness to undertake approximately 10% domestic/international travel.
Why Join ICON?
Our success depends on the quality of our people. That’s why we prioritize building a diverse culture that rewards high performance and nurtures talent.
We Offer a Competitive Benefits Package Focused on Well-Being:
- Generous Annual Leave entitlements.
- Comprehensive Health Insurance for you and your family.
- Competitive Retirement Planning offerings.
- Global Employee Assistance Programme providing 24/7 support.
- Life Assurance coverage.
- Flexible, Country-Specific Benefits including wellness programs and more.
Our Commitment to You:
At ICON, inclusion and belonging are fundamental to our culture and values. We are dedicated to providing an inclusive and accessible environment and are proud to be an equal opportunity employer.
Ready to be the guardian of digital quality and compliance for global clinical trials?
Apply now for the Senior Validation Engineer position in Chennai.
We encourage all interested candidates to apply. If you require a reasonable accommodation during the application process, please inform us.
