Senior Validation Engineer Job at iconplc (Blue Bell, PA or Raleigh, NC)

Senior Validation Engineer

iconplc

Location:
United States , Blue Bell, PA or Raleigh, NC

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Not provided

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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 have an incredible opportunity for a Senior Validation Engineer to join ICON’s IT Validation team. The Senior Validation Engineer will plan and lead validation activities for multiple complex projects of any size, which may be regional or global in scope, ensuring the activities conducted are fully compliant with industry regulations and guidelines as required by ICON, the FDA, EMA and other globally applicable regulations.

Job Responsibility:

Coordinate multiple validation activities with project teams, various departments, and external vendors to include: Installation Qualification (IQ)
System Testing
Regression testing
Backup and Restore
Disaster Recovery
Data Migration
and upgrades introduced through change control
Conduct meetings for a GxP Risk Impact Assessment (RIA) and 21 CFR Part 11/Annex11 Assessment
Assist in the creation of User Requirements Specification, Functional Requirements Specification, and Technical Design Specification
Create all System Delivery Life Cycle (SDLC) deliverables that are authored by Senior Validation Engineer
Review all System Delivery Life Cycle (SDLC) deliverables, provide constructive feedback, and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs) or Work Instructions (WIs)
Create, review, and update SOPs and WIs associated with ICON’s SDLC
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
Create, update, and present training material associated with all aspects of the System Delivery Life Cycle (SDLC) and regulations, such as 21 CFR Part 11, to ICON personnel
Represent IT Validation during sponsor audits, inspections, and conducting external vendor audits
Focus on meeting project schedules, conduct SDLC and Validation training, and collect metrics

Requirements:

10+ years of Computer System Validation experience (CSV), with GxP systems, and preferably medical imaging systems
Expertise in GxP
Strong communication skills, with the ability to convey ideas clearly and effectively
Experience with audit support and knowledge of FDA, EMA, and global regulations
Excellent time management skills, with the ability to prioritize tasks and meet competing deadlines
Bachelors Degree in Computer Science or relatable field

What we offer:

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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others

Additional Information:

Job Posted:
February 14, 2026

Employment Type:

Fulltime

Work Type:

Hybrid work

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