Senior Validation Engineer
About the role
This vacancy has now expired. Please click here to view live vacancies.
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 10%) domestic and/or international.
· *Must be able to plan and lead validation and qualification activities for multiple projects, 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 procedures and the FDA.
· *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 conduct 21 CFR Part 11 Assessment.
· *Assist Senior Business Analysts in gathering requirements from users and create user/system requirements specification.
- *Create and execute validation deliverables, including but not limited to Validation Plan, Test Scripts, Defect Management, Traceability Matrix, and Validation Summary Report.
-* Perform various types of testing, including but not limited to Black Box Testing, GUI Testing, System Testing, User Acceptance Testing, Functional Testing, and Regression Testing.
· *Must be able to review System Development 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 proficient in related 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.
· *Assist Senior Business Analysts in gathering requirements from users.
· *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.
· *Able to create, update, and present training material associated with all aspects of the System Deliverable 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.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
Day in the life
.png)
Teaser label
IndustryContent type
BlogsPublish date
06/06/2025
Summary
Building Connections that Drive Progress In an industry where collaboration is critical to advancing science and improving patient outcomes, networking is more than a professional courtesy - it’s
.png)
Teaser label
IndustryContent type
BlogsPublish date
05/29/2025
Summary
Blood Cancer Day Blood Cancer Day is a powerful reminder of the millions of individuals and families whose lives are affected by hematological malignancies every year. These diseases are complex,
.png)
Teaser label
IndustryContent type
BlogsPublish date
05/22/2025
Summary
World Schizophrenia Awareness Day 2025 Every year on 24 May, World Schizophrenia Awareness Day offers a vital opportunity to raise awareness, dismantle stigma, and celebrate the strength of individ
Similar jobs at ICON
Salary
Location
Bangkok
Department
Clinical Monitoring
Location
Bangkok
Remote Working
Home-Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
Principal CRA (Lead CRA Role), Home-Based, Bangkok Thailand As a (Principal CRA) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare inte
Reference
2025-120539
Expiry date
01/01/0001
Author
Youngae "May" ChoAuthor
Youngae "May" ChoSalary
Location
Mexico
Department
Clinical Operations Roles
Location
Mexico
Remote Working
Home-Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
As an Associate Project manager at ICON, you will play a pivotal role in supporting the coordination and management of clinical trials, contributing to the design, analysis, and advancement of treatme
Reference
2025-120551
Expiry date
01/01/0001
Author
Rita VillavicencioAuthor
Rita VillavicencioSalary
Location
Brazil
Department
Clinical Operations Roles
Location
Brazil
Remote Working
Home-Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
As a Senior Investigator Pricing Analyst, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2025-120452
Expiry date
01/01/0001
Author
Bruna DuarteAuthor
Bruna DuarteSalary
Location
Mexico, Mexico City
Location
Mexico City
Remote Working
Home or Office
Business Area
ICON Full Service & Corporate Support
Job Categories
Contracts Administration
Job Type
Permanent
Description
What you will be doing:Review and negotiate clinical site investigator contracts and budgets.Maintain communication with investigative sites, sponsors, and internal stakeholders regarding contract sta
Reference
JR130716
Expiry date
01/01/0001
Author
Daniela GuerreroAuthor
Daniela GuerreroSalary
Location
United States
Department
Clinical Operations Roles
Location
United States
Remote Working
Home-Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
We are looking for a CTL&D Analyst to provide support to CTL&D TA Leads for protocol specific training planning within assigned therapeutic area(s). Service/deliverables include support to deliver on
Reference
2025-120535
Expiry date
01/01/0001
Author
Jamie PruittAuthor
Jamie PruittSalary
Location
United States
Department
Clinical Operations Roles
Location
United States
Remote Working
Home-Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
As a CTA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2025-120530
Expiry date
01/01/0001
Author
Kala MurphyAuthor
Kala Murphy