Senior Validation Engineer job in

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ICON is looking for a Sr Validation Engineer to be based in Chennai. We are looking for someone with experience in computer validation and can ensure that the system is fully complaint with industry regulations and guideline. If you would like to be part of a department that has growth plans and can offer excellent training and development this might be the right opportunity for you.

Job Description

Must be able to plan and lead validation and qualification activities for multiple complex projects of any size, which may be regional or global in scope and are occurring at the same time, ensuring that the activities conducted are fully compliant with industry regulations and guidelines as required by ICON and the FDA.
Travel (approximately 10%) domestic and/or international.
Must be able to coordinate multiple validation and qualification activities with project teams, various departments, and external vendors. These activities include Installation Qualification (IQ); System Testing, which covers Operational Qualification (OQ), Performance Qualification (PQ), Regression testing; Backup and Restore; Disaster Recovery; Data Migration; and upgrades introduced through change control.
·Must be able to conduct meetings for a Risk Impact Assessment (RIA), Validation Risk Assessment and 21 CFR Part 11 Assessment.
·Must be able to create a User Requirements Specification, and assist in the creation of a Functional
Requirements Specification and the Technical Design Specification.
Must be able to create all System Delivery Life Cycle (SDLC) deliverables that are authored by Validation Engineer III or below.
Must be able to review all System Delivery Life Cycle (SDLC) deliverables, provide constructive feedback, and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs) or Working Procedures (WPs).
Must be completely proficient in all ICON Information Technology SOPs and WPs and possess a thorough understanding of computer system validation in order to be capable of approving all System
Delivery Life Cycle (SDLC) deliverables that are delineated for a Validation Engineer III or below.
Must be able to create, review, and update SOPs and WPs associate with ICON’s SDLC.
Must be able to 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.
Must be able to create, update, and present training material associated with all aspects of the System Delivery Life Cycle (SDLC) and FDA regulations, such as 21 CFR Part 11, to ICON personnel.
Must be capable of representing Validation Services during sponsor audits and conducting external vendor audits.
Focus on meeting project schedules; conducting SDLC, Validation, or Installation Qualification training; and collects metrics.
Keep supervisor and project managers informed of any validation or qualification issues.
Additional duties as deemed appropriate by the department head/designee.

*LI-GA1

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Senior Validation Engineer

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