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About the role
- Senior Validation Engineer leading compliance and validation activities for ICON's IT team. Managing multiple validation projects in accordance with industry regulations at office locations in the US.
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
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
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.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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