Senior Validation Engineer

ICON is looking for a Sr Validation Engineer with around 5 to 8 years of experience in Computer System Validation preferably in clinical systems.

This position works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors, exercises judgement within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. The candidate may also need to determine methods and procedures on new assignments and provide guidance to juniors

Job Responsibilities

• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
• 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.
• 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.
• Supervision- Mentor lower-level validation personnel and assist with their career development.
• Experience and Skills: Prior relevant experience in computer system validation, preferably in clinical systems.; a minimum of 4 years' experience in computer system validation, preferably in clinical systems. Bachelor's degree, or local equivalent, in computer science, mathematics, information systems, information technology or a related field.