ICON Strategic Solutions · 16 hours ago
Senior Validation Engineer
US, Raleigh, NC
Full-time
Hybrid
Senior Level, Lead/Staff
10+ years expICON plc is a world-leading healthcare intelligence and clinical research organization. They are seeking a Senior Validation Engineer to join their IT Validation team, responsible for planning and leading validation activities for complex projects to ensure compliance with industry regulations.
Pharmaceuticals
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
Qualification
Required
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
Benefits
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.
Company
ICON Strategic Solutions
ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services.
10001+ employees
H1B Sponsorship
ICON Strategic Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (1)
2021 (2)
2020 (3)
Funding
Current Stage
Late StageLeadership Team
Jennifer Alamo Linnell
VP, HR Business Partnering
Aimée Guzmán
External Partnerships Project Manager & Site Lead | Providing Services for J&J Innovative Medicines
Company data provided by crunchbase