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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
Senior Validation Engineer:
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 10%) domestic and/or international.
Must be able to plan and lead validation and qualification activities for projects of various sizes, which may be regional or global in scope and are occurring at the same time, ensuring that the activities conducted are fully compliant with industry regulations and guidelines as required by ICON and regulatory bodies such as FDA, MHRA, etc.
Must be able to coordinate multiple validation and qualification activities with project teams, various departments, and external vendors. These activities include Installation Qualification (IQ) System Testing, which covers Operational Qualification (OQ), Performance Qualification (PQ), Regression testing Backup and Restore Disaster Recovery Data Migration and upgrades introduced through change control.
Must be able to perform Risk Impact Assessment (RIA), Data Integrity Risk Assessment and 21 CFR Part 11 Assessment for systems, with inputs from operation users/system owners and providing guidance and/or recommendations to end users for the assessments.
Must be able to create and/or assist with creation of Requirements Specification.
Must be able to create, execute, and review validation deliverables, including but not limited to Validation Plan, Test Scripts, Defect Management, Traceability Matrix and Validation Summary Report.
Must be able to perform various types of testing, including Black Box Testing, GUI Testing, System Testing, User Acceptance Testing, Functional Testing and Regression Testing.
Must be able to review all System Delivery Life Cycle (SDLC) deliverables, provide constructive feedback, and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs) or Working Procedures (WPs).
Must be completely proficient in all ICON Information Technology SOPs and WPs and possess a thorough understanding of computer system validation in order to be capable of approving all System Delivery Life Cycle (SDLC) deliverables that are delineated for Validation Team.
Must be able to create, review, and update SOPs and WPs associate with ICON's SDLC.
Must be able to conduct and approve a Periodic Review of computer system validation documentation, including change control documentation, to ensure that the validated state of a system has been maintained over time.
Must be able to create, update, and present training material associated with all aspects of the System Delivery Life Cycle (SDLC) and FDA regulations, such as 21 CFR Part 11, to ICON personnel when needed.
Must be capable of representing Validation Team during sponsor audits.
Focus on meeting project schedules conducting SDLC, Validation, or Installation Qualification training.
Keep supervisor and project managers informed of any validation or qualification issues.
Additional duties as deemed appropriate by the department head/designee.
Education requirements:
Bachelor's Degree in Science.
Minimum of 6 years of experience as a Validation Engineer.
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 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.
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 to apply
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 37 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.
Job ID: 138399097
