Senior Validation Engineer

ICON plc • Raleigh, NC

1d • Hybrid

About The Position

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. Location: Office-Based (Average of 3 days per week) Blue Bell, PA Raleigh, NC

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

Responsibilities

• 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior