Project Engineer at Novartis handling critical site and global engineering projects and ensuring GMP compliance. Collaborating with cross - functional teams to solve complex engineering challenges.
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
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